Alabama, Arizona, California, Florida, Illinois, Nevada, New York, Ohio, Oklahoma, Oregon, Texas, and Virginia.
Kratom (Kr8om) Maeng Da Thai Pure Alkaloid Suspension Oil in 150 mg,
Kratom (Kr8om) MD  (Maeng Da Thai) Oil in 225 mg., 375 mg., and 150 mg. dosages.
Kratom (Kr8om) Premium Bali Alkaloid Suspension Oil in 135 mg., 200 mg., and 300 mg. dosages and Kratom (KR8om) Bali Custom Alkaloid Suspension Oil in 175 mg dosage
K SHOT 0.5 fl. oz (15 ml) 9 GRAMS OF HIGH QUALITY KRATOM LEAF PER BOTTLE   Botanical Supplement Shot 100% Natural  PURE ALKALOID CONCENTRATE OIL 100% NATURAL  Vegan, Kosher, Halal, and Ital friendly
100% NATURAL HERBAL MIND & BODY SHOT greenjoy   Sustained, Relaxed Energy  Supports Mood & Immune Functions   Relief of pain for aging bodies HERBAL SUPPLEMENT 2.0 fl oz (59 mL)    Formulated + MfG'd by NUEVOtanicals, LLC Fort Worth, Texas 76112   Distributed by:  Scientific Botanica I Solutions, LLC Chicago Illinois 60639
Kr8om Max3 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 3 capsules; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 10 capsules; Capsules are packed in a round, clear plastic screw-on lid container.  Dosage is ''1 capsule after a meal'', each capsules is ''4.4 g leaf equiv''.
Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 5 tablets; Kr8om Max10 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC. Fort Worth, TX 76112, 10 tablets; Tablets are packed in a round, clear plastic screw-on lid container.  Dosage is ''1 tablet after a meal'', each tablet is ''4.20 g Maeng Da leaf equiv''.
Green Malay/MD bulk in 1 gallon plastic jugs, no product label
Max powder in Ziploc-type freezer bags in 500 g increments, no product label
Enhanced Leaf Powder in Ziploc-type freezer bags in 500 g increments, no product label; Bulk Raw (non-extracted) Kratom Leaf Powder in Ziploc-type freezer bags in 500 g increments, no product label.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product distributed to local Supermax Supermarket Stores
FDA inspection disclosed product labels with undeclared milk.
The products were distributed in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
BBL Port A Cul tubes, catalog number 221606.  Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
The products may exhibit indications of excessive oxidation.  Excessive oxidation may affect the viability of anaerobic microorganisms.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607.  For patient sample collection.
Worldwide Distribution-US (nationwide), Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
VITROS 4600 Chemistry System, Software Version 3.2 & Below.   Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Product Code: 6802445 Unique Device Identifier No.: 10758750012343
255 units total (131 domestically & 255 internationally)
Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.
VITROS 5600 Chemistry System, Software Version 3.2 & Below.   Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
Product Code: 6802413 Unique Device Identifier No.: 10758750002740
1895 units total (907 domestically & 988 internationally)
Worldwide Distribution - US Nationwide, Brazil, Chile, Mexico, Australia, Hong Kong, India, Taiwan, Belgium, Denmark, France, Ireland, Italy, Portugal, Romania, Spain, Sweden and the UK.
VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below   Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing.
2,387 units Total   (987 domestically & 1400 internationally)
Software anomaly regarding urine samples that require acidified pretreatment.  The software has allowed urine samples for assays that require acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed.
Assay Data Disk (ADD), All DRV versions that support product within expiry dating   Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assay testing
Product Code: 6801876 Unique Device Identifier Numbers: 10758750001576
NY, IL, TX, UT, MN, AL, CO, CA, WA, VA, MA, AZ, GA, KY, HI, OH, NC, MI, FL, PA, MO, MS, VT, ND, IN, NH, NJ, OR, TN, OK, NE, WI, MO, CT, LA, SC, AR, PR
Packaging label does not match individual product labeling.  Outside packaging  may have incorrect Lot/Exp and product identity.
Rugby Poly Vitamin Liquid with Iron, 50 ml
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by  Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by  Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Class I Recall - Worldwide distribution -- US, including the states of AL, AZ, DC, FL, MI, MO, NJ, NY, OR, PA, TX, and WV; and, countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Libya, Mexico, Mongolia, Mozambique, Netherlands, Norway Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Unites States, and Venezuela.
FLOW-i Anesthesia System   The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
Worldwide Distribution - US including CA, FL, NJ, TX, WA, ******Internationally: Korea, Russia, Kuwait, Canada, Greece, Lebanon, Turkey, Egypt, Saudi Arabia, China, Armenia, Azerbaijan, Australia.
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
Blood product, which did not meet the acceptable product specifications, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, which were labeled with an incorrect expiration date, were distributed.
All located within CA.  No foreign distribution.
Seasoning Fish Filet   Ingredients: Mixed Fish, Sugar, Salt, Monosodium Glutamate, Sorbic Acid    Bulk cases with 12kg of fish fillets which are packaged in clear plastic.  The label does not declare the type of fish, other ingredients in the product, or nutrition facts.
Roxy Trading, Inc. is recalling Seasoning Fish Filet due to the label missing an ingredient statement. Also, the fish was labeled as Grouper when it has been confirmed to be a mixture of fish.
Worldwide Distribution - Nationwide Distribution including Puerto Rico.,  and the countries of  :  Ireland, Spain, Slovenia, Great Britain, Netherlands, Norway, Mexico, Egypt, Czech Republic and Spain.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Blood chamber connection leaks during the use of the CRIT-LINE Blood Chamber
Bio Armor Carno Pump Plus Electrolytes 40 servings (Blue Raspberry),  Distributed by Reaction Nutrition, Carnegie, PA
Work out support nutritional supplements manufactured on shared equipment may contain unknown amounts of whey protein and soy.
Bio Armor Carno Pump Plus Electrolytes 40 servings (Cherry Lime),  Distributed by Reaction Nutrition, Carnegie, PA
Bio Armor CreaMatrix 306g 60 servings Unflavored, Distributed by Reaction Nutrition, Carnegie, PA
Bio Armor CreaMatrix 60 servings Blue Raspberry, Distributed by Reaction Nutrition, Carnegie, PA
Bio Armor CreaMatrix 60 servings Cherry Lime,  Distributed by Reaction Nutrition, Carnegie, PA
Bio Armor Glutamine 150 Grams and Bio Armor Glutamine 500 Grams, Distributed by Reaction Nutrition, Carnegie, PA
REACTION RECOR: Amino Action- 500g (Cherry Lime), Distributed by Reaction Nutrition, Carnegie, PA
Work out support nutritional supplements manufactured on shared equipment may contain unknown amounts of whey protein.
REACTION RECOR: Amino Action- 500g (Glacier Blue), Distributed by Reaction Nutrition, Carnegie, PA
RN BlueChip: Glutamine, L-Glutamine Powder, 400 grams, Distributed by Reaction Nutrition, Carnegie, PA
RN BlueChip: Creatine, Creatine Monohydrate, 400 grams, Distributed by Reaction Nutrition, Carnegie, PA
REACTION RECOR: Pre Action- 336g Orange Xplosion, Distributed by Reaction Nutrition, Carnegie, PA
REACTION RECOR: Pre Action- 336g Glacier Blue, Distributed by Reaction Nutrition, Carnegie, PA
REACTION RECOR: Amino Action- 500g (Island Breeze), Distributed by Reaction Nutrition, Carnegie, PA
Worldwide distribution.  US nationwide, Uruguay and Canada.
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
The Astral device allows clinicians to disable all alarms including those that detect circuit disconnection.  Inappropriate disabling of alarms in ventilator dependent patients can lead to hazards of insufficient ventilation and insufficient expiratory pressure which can result in major severity harm.
Worldwide Distribution. US nationwide,  Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Hong Kong, India, Norway, Spain, Trinidad and Tobago, and United Kingdom.
Roscoe Mini Neb Compressor User Manual for the NEB-ROS   Product Usage:  Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and storing a Roscoe Medical Nebulizer to reduce user damage (wear & tear) to the power cord.
Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Congo, Democratic, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, Runion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Gemini 16 PET/CT System  (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity PET/MR  (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Gemini GXL 16 Slice  (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Gemini LXL 16 Slice  (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
TruFlight Select PET/CT 16-slice  (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Distributed to the states of KY, MN, NJ, UT, & WI.
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc.   Used to administer fluid and drugs intravenously.
Product Reorder Number: 537235C; Lot #2761409
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
CT, NJ, NY, MA via Golden Krust stores and CA, FL, GA, IL, MD & NC via distributors
Golden Krust SOYA PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN
expiration dates: 1/24/2015 through 2/26/2016
Golden Krust Caribbean Bakery & Grill has recalled their Jamaican Style Shrimp & Soya Patties due to the presence of undeclared egg.
Golden Krust Caribbean JAMAICAN STYLE SHRIMP PATTIES, NET WT. 17.2 LBS, 50 UNBAKED, KEEP FROZEN
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205.      Product Usage:  For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Serial #: ALL HeartWare HVAD systems currently in use.
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6AI-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- K030055,K003429 LPH, MEH Metric Femoral Components.   Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6AI-4V, Standard Length Porous Plasma.  Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar components.
Biomet Cobalt-Chrome Femoral Hip prosthesis Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -; MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Worldwide distribution.  US Nationwide, Australia, Bermuda, Brazil, Canada, Chile, China, France, India, Italy, Norway, Portugal, Spain, Sweden, and the United Kingdom.
enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack Entry and Exit Module and/or Rack Exit Module (Product Codes 952020-EG/6844086 or 952019-EG/6844103), Storage Rack Slim 100 positions or Storage Rack 180 positions (Product Codes 952075 or 952073).     COMMON NAME: enGen Track System.  The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management.
45 units worldwide (Domestic: 19 units, Foreign: 26)
Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid.  Sample cross-contamination may occur with an uncapped tube in the rack.
Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates).     Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Lot Number:  646595 and 646596 Expiration date:  19May2015
Product may be contaminated with Listeria monocytogenes.
Worldwide Distribution-US (nationwide) and the countries of  Australia, Singapore, Canada, and Thailand.
EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004.   The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.
EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002.   The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.
651 stores of 1 consignee located in CA (San Diego and Los Angeles area only).  No distribution to other states or foreign countries.
evolution FRESH brand Fresh Berries & Honey, Nonfat Greek Yogurt with Strawberries, Blueberries, Pure Honey, & Granola;   NET WT 6.5 OZ/184 g;  Perishable Keep Refrigerated;    SKU 11048364;  Made Exclusively For: Evolution Fresh, Inc. 2401 Utah Avenue South Seattle, WA 98134 USA.    The product is packaged in clear plastic containers that are segregated into three sections with fruit, granola, and yogurt and honey.
Product recalled due to undeclared almonds.
Oklahoma Blood Institute - Sylvan N Goldman Center
Blood products, donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search, prior deferral due to testing, were distributed.
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04
Lot #: B201B, Exp April 2015; B346D, Exp August 2015.
Labeling: incorrect or missing lot number and/or expiration date
These items were distributed to retail stores in Virginia, Maryland, New Jersey.
1-lb, 2-lb and 10-lb bags of Soybean Sprouts in clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated
Good Seed Inc. of Springfield, VA is recalling all packages of soybean sprouts and mung bean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems.     The contamination was discovered after sampling by the Virginia Department of Agriculture and Consumer Services Food Safety Program and subsequent analysis by the Virginia Division of Consolidated Laboratory Services revealed the presence of Listeria monocytogenes in the product.
1-lb, 2-lb and 10-lb bags of Mung Bean Sprouts in clear plastic bags labeled GOODSEED Mung Bean Sprouts Keep Refrigerated
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF.    Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.  .
Catalog number GC070RF, Lot 120709i-cm, Expiry 7/31/2014.
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
All Serial Numbers   Models:  1. 05458544001, Accu-Chek Combo Kit mg US/English version.  2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version.  3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN.  4. 05391750001, Accu-Chek Spirit Combo Demo Pump  US.  5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up.  6. 04540492001, Accu-Chek Spirit Pump Kit US/CA.  7. 04759729001, Accu-Chek Spirit Replacement Pump.
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia up to diabetic ketoacidosis (DKA) with a serious outcome.
Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head &#38; Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No.  TS101DC,  Lot numbers JC924165 and below; Rx Only, STERILE EO
AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA,  Foreign: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg,  Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore,   Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205.    Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Complaints with the HVAD Retraction of Pins within the driveline connector.
Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia, Austria, Croatia, Denmark, France, India, Isreal, Bermuda, Curacao, Cayman Islands, Jamaica, Canada, Bangladesh, Cyprus, Estonia, Greece, Indonesia, Italy, Kazakhstan, Latvia, Macedonia, Norway, Portugal, Russia, Slovakia, Spain, Taiwan, UAE, Kenya, Lithuania, Malaysia, Philippines, Qatar, Saudi Arabia, Slovenia, Sweden, Tunisia, United Kingdom, Kuwait, Luxembourg, Netherlands, Poland, Romania, Singapore, South Africa, Switzerland, Turkey, and Vietnam.
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.
Lot number 49059UN14, Expiration data 04-MAR-2016.
The product is leaking from the cap and crystallization was noted as present around the cap.
Distributed to 29 retailers nationwide.  No foreign, government/military/VA accounts.
250cc White Plastic Container containing 120 capsules, labeled Natural Creations New Zealand Colostrum, Colostrum Supplement, MFG. FOR: Natural Creations, Woodbine, IA 51579, 712-647-1600
Lot numbers: 1112301 (exp. 1/15) and 3102914 (exp.  2/17), all products with all expiration dates.
Natural Creations announces allergy alert and voluntary recall of New Zealand Colostrum dietary supplement due to unidentified allergen inclusion (milk).
Worldwide Distribution - US (nationwide) and Internationally to Australia, Estonia, Italy, Romania, Sweden, Austria, Finland, Kuwait, Saudi Arabia, Switzerland, Bahrain, France, Netherlands, Slovenia, Turkey, Belgium, Great Britain, Oman, Slovakia, South Africa, Bulgaria, Greece, Poland, South Africa, United Arab Emirates, Czech Republic, Hungary, Portugal, Spain, Denmark, Ireland, and Qatar.
ClearSight, Model No. EVHRS Heart Reference Sensor.  The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged.
US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Unilateral external fixation ankle clamp   Product Usage:  Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed.  This prevents complete range of motion and if pushed too far may loosen the pin from the bone.  A revision surgery may be necessary to adequately reconnect the fixator to the bone.
Mother's Milk was labeled as ''Mature milk''.  This is breast milk and was donated from nursing mothers.  Product is packaged in glass bottle, 4 oz.  The logo of Mother's Milk Bank is observed on a label.  All milk was shipped frozen.
Mother's milk from batch #294 was recalled due to finding of plastic fragment in one bottle
Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4'' (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch   For use in patients undergoing cardiopulmonary bypass.
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Worldwide Distribution - US Nationwide in the states of AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, WI and countries of Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy.
M/L Taper with Kinectiv Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component)    Product Usage:  Usage:  Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product.  Reasonable probability of adverse biological response and subsequent revision
Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Bimix (PHENT;PAP) (N), solution, (10/300) 1 - 30 mg/mL, injectable, 5ml vial, Rx only, compounded by Montana Compounding Pharmacy in Missoula, MT.
Glutathione INHALATION (PF), solution, 100mg/mL, 4 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT.
Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT
Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT
Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
Leksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Memory can become corrupted when creating a fused study via drag & drop in Leksell GammaPlan 10.2.
US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
ORTHOFIX  Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
GE OEC Brivo 865 plus, Mobile X-ray system
Nine (9) Brivo 865 laser aimer assemblies (part number 520002DW)were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
Distributed in the states of CA, IL, NC, and NY.
Ally Uterine Positioning System (Ally UPS)  used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures  Model: Ally UPS
Design of device may expose user to injury to fingers or body parts
Valeant Pharmaceuticals North America LLC
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.
Failed Dissolution Specifications: High dissolution at 1 hour time point.
Worldwide Distribution - US Nationwide in the states of CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI and the countries of Australia, Switzerland, Chile, Canada, and Spain.
R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STERILE EO.   Product Usage:  The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STERILE EO.   Product Usage:  The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO.   Product Usage:  The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO,    Product Usage:  The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STERILE EO.   Product Usage:  The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
Distributed in the states of MS, MD, PA, and TX.
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25.   Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Incidence of breakage is higher than expected.
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-200T-25.   Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-250T-25.   Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
Subpotent Drug; out of specification results for heparin raw material
The Optigun Ratchet is a hand-held cement gun for use with Optivac.  The Optigun Ratchet is used to deliver bone cement from the Optivac.
Catalog number: 419500 Lot number: 0101296012
The pin which maintains the knob button, may disconnect and become lost.  This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.
AGFA DX-D 100 is a mobile digital radiography x-ray system
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.