Pure Whey Vanilla , Dietary Supplement Packaged under the labels:  Maine Natural Health and Stronger Faster Healthier  Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that the label fails to declare the allergen milk
Protein supplement fails to declare allergen: milk
Pure Whey Chocolate, Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz.
All lots codes that the label fails to declare the allergen milk,
Protein supplement fails to declare allergen milk
Pure Whey Natural Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10  oz
Recovery Vanilla (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier  Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that the label fails to declare the allergens: milk, shellfish
Protein supplement fails to declare allergens: milk, shellfish
Recovery  Chocolate (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that fail to declare the allergens: milk, shellfish
Recovery Natural (also labeled Post Workout), Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Pack Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that fail to declare the allergens: milk, shellfish an
Endurance Daily Vanilla Dietary Supplement Packaged under the label:  Stronger Faster Healthier and Mainer Whey  Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that fail to declare the allergen  milk
Endurance Daily Chocolate  Dietary Supplement Packaged under the label:  Stronger Faster Healthier  Coconut, Lime  Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes
All lots codes that fail to declare the allergens milk
Protein supplement fails to declare allergens milk
Endurance Pre Race Lime , Dietary Supplement  Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz),  and 30 gram sizes
All lots codes that fail to declare the allergens: milk & shellfish
Endurance Pre Race Pina Colada, Dietary Supplement  Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz),  and 30 gram sizes
All lots codes that fail to declare the allergens: milk
Protein supplement fails to declare allergens: milk
Endurance In Race Coconut Dietary Supplement  Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz),  and 30 gram sizes
Endurance In Race Lime Dietary Supplement  Packaged under the label Stronger Faster Healthier Pack. Packaged in: 2 lb (32 oz),  and 30 gram sizes
Protein supplement fails to declare allergens: milk and coconut
Daily Balance Vanilla Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Daily Balance Chocolate Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Daily Balance Natural Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Hunger and Weight Vanilla  Dietary Supplement Packaged under the labels Stronger Faster Healthier Whey: 2 lb (32 oz),  and 10 oz sizes
Hunger and Weight Chocolate Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Fortified Vanilla Dietary Supplement  Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Fortified Chocolate  Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Rejuvenate Vanilla  Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
Rejuvenate Natural Dietary Supplement Packaged under the labels Stronger Faster Healthier: 2 lb (32 oz),  and 10 oz sizes
All lots codes that fail to declare the allergen milk
One consignee in each of three states: IA, NE, and SD.
Bulk PEG GROW'EM BASE MIX (SC), 99226 SC 1311. Firm name on the label is Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.
Hog feed grower base mix was contaminated with salt.
Bulk JEM GRAIN 102 CTC/DENAGARD, MEDICATED, Active Drug Ingredients: Tiamulin 35 g/ton, Chlortetracycline 400 g/ton, Custom Mix Not For Resale or Redistribution,  Product Code   187201_CD. Manufactured by Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.
TRITECH NURSERY II 600 AN (SC), 471023-N SC 1311, packaged in 50-lb. bags. Manufactured for Tritech, Inc. Huron, SD 57350. Cargill Animal Nutrition, General Office, Minneapolis, MN 55440.
HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC  63323-469-01
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Distributed in the states of IL, and TN, and the countries of  Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028.   The Allura Xper FD series are intended for use on human patients to perform:  Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035.    The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Blood product, collected from a donor whose  suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Integra LifeSciences Corporation received 2 complaints that the USB port on the Licox Pt02 monitor does not consistently provide the user the ability to extract the Pt02 trend data according to the User's Manual for the device.
Micro Labs Usa, Inc                                    S
Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of  Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction.     Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled:  Part No.                       DePuy Synthes Lot No:                  MFG Lot No:  254400520                          ABC22844                                  C22844                                                 ABC22845                                  C22845                                                 ABC34279                                  C34279                                                 ABC34280                                  C34280                                                 ABC4107                                     C4107                                                 ABC4108                                     C4108                                                 ABC4112                                     C4112                                                 ABC4113                                     C4113                                                 ABC50741                                  C50471  254400521                          ABB13662                                   B13662                                                  ABB19116                                  B19116                                                 ABB19117                                   B19117                                                 ABB19118                                   B19118                                                 ABB35392                                   B35392                                                 ABB35393                                   B35393                                                 ABB39835                                   B39835                                                 ABB41384                                   B41384                                                 ABB46872                                   B46872
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
American National Red Cross, Penn Jersey Region
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood products, collected from donors with unsuitable health histories, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 6-10 piece packages (60 pieces), 6 PAK, Retail UPC 0 12546 10102 8; 2)Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 7-6 PAK packages (420 pieces), Retail UPC 0 12546 0
Best When Used By 4 Oct 2015 - 11 Oct 2015
Mondelez Global LLC is conducting a voluntary recall of  Chiclets Chewing Gum due to undeclared soy lecithin on the label.
1) Chiclets Peppermint Gum,  6-10 piece packages (60 pieces), Retail UPC 0 12546 10105 9; 2)Chiclets Peppermint Gum, 20 - 12 piece packages (240 pieces), Retail UPC 0 12546 02501 0, Case UPC 1001254 3)Chiclets Peppermint Gum, (12 pieces), Retail UPC 0 12546 10128 8; 4)Chiclets Peppermint Gum, 7-6 PAK packages (420 pieces), Retail UPC 0 12546 02601 7, Case UPC 000125461010
1)Best When Used By 12 Oct 2015 - 6 Nov 2015; 2)Best When Used By 31 Aug 2014 - 8 Nov 2015; 3)Best When Used By 31 Aug 2014 - 8 Nov 2015; 4)Best When Used By 12 Oct 2015 - 6 Nov 2015
1) Chiclets Fruit Flavor Gum, 12 piece, Retail UPC 0 12546 10628 3; 2) Chiclets Fruit Flavor Gum, 20 - 12 piece packages (240 pieces), Retail UPC 0 12546 02503 4, Case UPC 10012
Best When Used By 30 Aug 2014 - 6 Nov 2015
Chiclets Gum, 200 - 2 piece packs (400 pieces), Retail UPC 0 12546 02509 6, Case UPC 10012546108499
Best When Used By 2 Sep 2014 - 28 Dec 2015,
Blood products, for which donor screening testing may not have been performed according to manufacturer's specifications, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor who disclosed  history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.
Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.
Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each..    Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)
The caster may separate completely from the device frame causing injury to user.
US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Persona Stemmed 5 Degree Cemented Tibia     Product Usage:  This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the femoral condyle.  Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.  Moderate valgus, varus, or flexion deformities.  The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.  This device is intended for cemented use only.
The American National Red Cross - Southern Region
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, in which Viral Testing/Testing performed, interpreted, or documented incorrectly, were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g)
Undeclared color additives (FD&C yellow 5 & 6 and FD&C Red 40)
Blood product, collected from a donor who disclosed travel history that warranted deferral, was distributed.
Blood products, that were not quarantined after receiving information concerning post-donation illness, were distributed.
US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
Bard PerFix Light Plug     The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.
Oregon Compounding Centers, Inc. dba Creative Compounds
Unexpired veterinary sterile injectable drug is recalled due to lack of sterility assurance.
CYCLOSPORINE-E PLUS 2% OPHTHALMIC, 5 mL per package
Unexpired veterinary sterile ophthalmic drug is recalled due to lack of sterility assurance.
POLYSULF GLUCOSAMIN GLYCAN 10% INJECTABLE, 30 mL per package
US distribution:  AL, AZ, AR, CA, CO, CN, DC, FL, GA, HI, ID, IL, IN, IA, KN, KY, LA, ME, MD, MI, MN, MS, MO, NB, NV, NY, NC, ND, OH, OK, OR, PN, RI, SC, SD, TN, TX, VA, WV, WI.  Foriegn:  Austrialia, Brazil, Canada, China, Ecuador, India, Korea, Mexico, Pnama, and Thailand.
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side force on the table column, or pressure on the base of the table.   Severe damage to the shrouds may prevent the user from raising or lowering the surgical table.
Domestic Distribution:  AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA.  Foreign distribution:  Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt,  France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia,  Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
&quot;The orientation of images is displayed incorrectly. When operator chooses gantry on the right side from operation console, and the patient position is HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not consistent. &quot;L&quot; and &quot;R&quot; of scan images are reversed and this is not consistent with the patient actual position.  &quot;When a surview which is longer than 557mm is stopped by using Abort function during the scan process, the position of scan box in surview image is not correct.  &quot;For dental applications, when a patient scan is taken with Gantry tilted, and the tilt angle falls in the range from 1 to -1 degree (not including 0 degree position), the data post-processing may not operate normally, the images may not be displayed.  &quot;If the user stops a surview using the Abort function during the second part of the scan the positions of the scan box are not consistent.
OEC UroView 2800.   The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems.
OEC MiniView 6800.   The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
FlexiView 8800 Digital Mobile Imaging System.   The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
Series OEC 9800.   The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
Nationwide Distribution including Puerto Rico.
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
model number 10280959, with serial numbers 1000-1599
A cable inside the C-arm systems may have been routed in an inappropriate manner.  Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated.  Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.
AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI.
365 Organic Raisin Granola in 17 ounce (482 gram) cardboard cartons; 12 cartons per case.  UPC: 099482448738
365 Organic Fruit and Nut Granola was packed in boxes labeled for 365 Organic Raisin Granola.  365 Organic Fruit and Nut Granola contains pecans, almonds, and coconut.  The boxes of 365 Organic Raisin Granola only lists almonds in the warning statement.  The affected product has the potential to contain additional tree nuts not listed in the warning statement.
US Distribution including the states of NC, IA, IL and KS.
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Lot Number:  0007244836  MODEL: LA6JR40K
Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the distal tip of the catheter. The entire lot will be recalled from customer sites.
Blood product, collected from a donor with a risk factor associated with Creutzfeldt-Jacob Disease, was distributed.
Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, and Switzerland.
GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01       Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1  Model: MXKPHS01       Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues
Blood product, for which donor eligibility was not complete, was distributed.
Blood products, for which routine testing was not  documented, were distributed.
Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system.    Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
21,754 units (21,222) in the U.S. and Puerto Rico)
Firm has identified a small number of Oximetry Cables with crossed-internal wires.  The effect on performance when these wires are crossed is that when a low SpO2 value is measured, a high SpO2 value would be displayed on the monitoring device.  Additionally when a high SpO2 value is measured, a low SpO2 value would be displayed on the monitoring device.
Lightly Roasted Organic Carob Powder, 1lb and 5lb bags
Possible risk of contamination from Salmonella
Publix Asian Mix, 14 oz. clamshell containers
UPC: 41415-20286, All sell by dates between 01/03/15 and 02/03/15, All Lot Codes.
Product contains peanuts that are not declared on the label.
Distributed in the states of ND, VT and TX.
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg.     A growth supplement for the isolation of Legionella.
Lot Number:  1451506 Expiration:  26Feb2016
Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
Red Blood Cells Leukocytes Reduced Irradiated
Blood product, collected from a donor who travelled to an area considered endemic for malaria, was distributed.
Worldwide Distribution US (nationwide) including PR and the states of AL. AZ. AR, CA, CO, CT, IL, IN, KS, KY, MD, MA,MI, MN, MO, NY,NC, OH,OR, TN, TX, VA, and WA, and the countries of ARGENTINA, AUSTRALIA, BRAZIL, CANDA, GERMANY, FRANCE, GREAT BRITAIN, LEBANON, PANAMA, SOLOMON ISLANDS, SWEDEN, and COLOMBIA.
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850.   Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117.   MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652    MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
American Red Cross Blood Services Appalachian Region
Blood product, labelled with incorrect expiration date, was distributed.
Blood products, not prepared in accordance with specifications, were distributed.
Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by  Greenbrier International, Inc Chesapeake, VA 23320
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into boxes of Assured Naproxen Sodium Tablets, USP
Cardiohelp-I System    Product Usage:  A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a &quot;Battery Needs Service&quot; message after startup of the units when using either AC or DC power
Vanilla Pro-Med. 100, Vanilla Pro, High Protein Instant Shake, Net Weight .0935 oz, Distributed by Our Life Health, Savannah, GA
Foreign matter found in product; steel wool.
Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.
GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and  Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM, H3000YS, H2400YJ, H2400YK.      Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
GE Healthcare Varicam/VG and VG Hawkeye devices.   Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD.      Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system.  Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS.     Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system.  Models H3100RC, H3100RD, H2401LW.      Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.  This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.
Optima NM/CT 640, Models H3100YA, H3100YC.      Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ.   Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories
Worldwide Distribution - US Distribution including the states of FL, KY, MN, MA, PA, UT, NY, VA and CA., and the countries of Algeria, Australia, Argentina, Austria, Belgium, Brazil, Bulgaria, Cameron, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Latvia, Macedonia, Mexico, Netherlands,Pakistan, Peru, Poland, Portugal, Rep. Korea, Romania, Russian Fed, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tadjikistan, Taiwan,Turkey, Unit. Arab Emir and Vietnam.
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi)   For in vitro diagnostic use with IMMULITE Systems Analyzers  for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.
Catalog Number: LCLCM, Lot Number: 0019, Siemens Material Number: 10385383, IFU Reference: PILCLCM-11 {24}, 2014-02-19; PINLCLCM-11{24}, 2014-02-19; PIELCLCM-9{24}, 2014-02-19
2212 units (92 units domestically & 2120 units internationally)
A typographical error regarding the expiration date was identified in the control module instructions for use.
Nationwide Distribution including the states of TX, CA, OH, MS, VA, IL, TN, GA, CA, FL, and AZ.
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees.   The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head.
A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly.  Specifically, the threaded handle has been welded backwards on the template resulting in the cutting angle being the reverse of what it should be.
Distribution pattern indicates distributors located in CA and CO; however the firm also sold 135 cases online via their website.
Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz.  SKU: 7 05105 50171 0    Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz.   SKU: 7 05105 50161 1    Description of the Product:  - 32 oz (1 quart):  - The product is consumed in individual clear plastic bottles.  - Each bottle has a white label.  - There are 12 bottles in a case.    - 11.7 oz:  - The product is sold in individual clear plastic bottles.  - Each bottle has a white label.  - There are 12 bottles in a case    Product of Thailand  Distributed by Exotic Superfoods  www.exoticsuperfoods.com  NY e-mail: info@exoticsuperfoods.com  CA e-mail: caliinfo@exoticsuperfoods.com
It appears that these batches were not subjected to 5-log reduction as part of their processing.
Pride of Africa brand Semo ''Semolina'', Net Wt. 5 lb., UPC 016712016918  --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252-5220
Label review revealed the product contains undeclared wheat.
Pride of Africa brand Farina, Net Wt. 5 lb. (2.27 kg), UPC 016712016840  --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252-5220
Avocados packed in a brown cardboard box with green print.  Unity Groves Pride of the Redlands Florida Avocados 25399 SW 157 Ave Homestead, FL 33031
No known lot codes.  The avocaods were recieved by the recalling firm on 10/10/14.
The recalled product tested positive for Salmonella contamination.
Multiple Countries; Multiple U.S. States
Digoxin Immune Fab (Ovine), with incorrect prescribing information, was distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Worldwide Distribution - USA (nationwide) and Internationally to Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Bekgium, Bermuda, Chile, China, Croatia, Dominican Republic, Estonia, Finland, France, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mauritius, Mexico. Morocco, New Zealand, Nigeria, Northern Ireland, Norway, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, singapore, Slovenia, South Africa, Spain, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam, and West Bank.
Fisher & Paykel Healthcare (FPH) IW900-Series Infant Warmer   Fisher & Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly    It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units.    Infant Warmers Model Number (REF)  IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX    Spare Parts Model Number (REF)  043041129, 043041130, 043041131, 043042359, 648040142
Affected Serial (SN) and Lot (LOT) Numbers Infant Warmers: 071116ZZZZZZ - 090810ZZZZZZ    Spare Parts: 071116 - 090810
Nationwide (U.S.): 661 Infant Warmers and 180 Spare Parts, Internationally: 2,451 Infant Warmers and 280 Spare Parts
Fisher &amp; Paykel Healthcare is issuing this voluntary recall notice because it has had two confirmed reports of breakage of the nut that secures the heater head in place. Breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. The heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.   Our investigation has determined that the cause of the incidents is a manufacturing fault that is limited to two batches of nuts used only in the manufacture of certain lot numbers of Infant Warmers and spare parts.
TBI dba New England Eye & Tissue Transplant Bank