Worldwide Distribution - USA (naitonwide) and Internationally to  Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.    SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.     Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.    SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV.     CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.     SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patients physiological (SPECT) and anatomical (CT) images.     Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization.    The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification.     The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.     SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV.     CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.     SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.     Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
1) Symbia Intevo 6: Product Number: 10764803; Serial Numbers: 1001 ; 1002 ;    2) Symbia Intevo 16; Product Number: 10764804; Serial Numbers: 1001 ;  1002 ;    3) Symbia Intevo Excel; Product Number: 10764801; Serial Numbers: 1001 ;  1002
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
GOLD STAR'S FINEST COLD SMOKED STEELHEAD, Net Wt. (To Be Weighed At Time of Sale).  UPC 021 143140026.  Product is sold in a Vacuum Pack with blue and gold label.  PERISHABLE.  KEEP REFRIGERATED.  Distributed by: Gold Star 570 Smith Street Brooklyn, NY 11231, 718-522-1545.
Gold Star has recalled GOLD STAR'S FINEST COLD SMOKED STEELHEAD due to Listeria monocytogenes contamination.
Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.
Lumbar Extension Machine: usage- Physical Therapy
Review of DHR's revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.
Cervical Extension Machine:usage- Physical Therapy
International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.   Usage:Femoral implants
Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's   HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.
Product Codes: 5C4471(R), 5C8310(R); Serial Numbers: All serial numbers
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
Synthes Small Electric Drive (SED), The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and hard tissue
All lots of the affected Small Electric Drive (SED) (part number 05.001.175) are being recalled due to reports that the device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
Horiba Instruments, Inc dba Horiba Medical
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.  The defect would result in  a  false high or false low results for HbA1c and false high results  for magnesium, lactic acid, and CO2.
Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws.  Various instruments are also available for use by the surgeon to facilitate implantation of the device.   Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
2816 approx.units ( 2688 units US and  128 OUS)
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
US Distribution to states of: AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WV.
CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device   ***The involved units are those with the newest version of a panel PC referred to as POC-127.  These panels are identified by serial number. ***    The truFreeze is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures. The truFreeze is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
An increase in complaint trending for a loss of audible sound associated with the timer has been observed.
Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.
Failed Tablet/Capsule Specifications: Complaints of empty capsules received.
Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model  Number VS3000    The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
Worldwide Distribution - USA including AL, AZ, CA, CT, FL, GA, IL, KS, LA, MD, MI, MK, MS,  NC, NH, NJ, NY, OH, OK, PA, RI, SC, TX, VA, WA, WI and Internationally to Canada.
Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
The operating tables which are operated with the affected remote controls (all serial numbers): Mobile column JUPITER System U, Material no. 4500113; Mobile column JUPITER System Miyabi U, Material no. 1574977; Operating table column JUPITER SM 360 U, Material no. 1389824; Operating table column JUPITER SF U OCE, Material no. 1622774; Stationary column JUPITER System U, Material no. 4500112; FLOOR MOUNTING COLUMN JUPITER U, Material no. 1276277; Floor mounting column JUPITER 360 U, Material no.1389826; Operating table JUPITER UNIVERSAL U, Material no. 4500170; OR-TABLE JUPITER UNIVERSAL CARBON U, Material no.1223188.
Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
Worldwide Distribution: US (nationwide) and country of: Canada.
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085    Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test results that exceeds our acceptance criteria for this product. Siemens has observed a positive shift up to 12% at MYO concentrations within and above the reference range of the assay. Depending on quality control limits, this drift may not be detected. The degree of potential drift in MYO concentrations observed has negligible clinical impact.
Cilantro Flakes Organic, sold under private label Azure Farm, Net wt. 4 oz. or 1 lb. Product is packed in the heat seal poly bag.   The 4 oz. bag has UPC 8 70722 00256 5.  The 1 lb. bag has UPC 8 70722 00255 8.    The 4 oz bag is labeled in parts: ''***Cilantro Flakes Organic***GLUTEN FREE GMO-FREE***Azure Farm***Net Wt 4 oz (113.4g)***Distributed by: Azure Standard Dufur, OR 97021***''.    The 1 lb. bag is labeled in parts: ''***Cilantro Flakes Organic***GLUTEN FREE GMO-FREE***Azure Farm***Net Wt 1 lb (453.5g)***Distributed by: Azure Standard Dufur, OR 97021***''.
Azure Farm Cilantro Flakes Organic, 1 lb. and 4 oz. bag size, is recalled due to potential to be contaminated with Salmonella.
AK, AZ, CA, CO, CT, DE, GA, ID, IL, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT ,NE, NV,NH, NH, NY, ND, OH, OK, PA, SC, SD, TN, VA,  WA, WI, WY.
Abdallah Milk Chocolate Bites CARAMEL, Net Wt 4.5 oz. (127g), UPC  7 6668407116 2, Ingredients: Pure milk chocolate (sugar, chocolate liquor, cocoa butter, whole milk, soy lecithin (an emulsifier), vanilla), corn syrup, sweetened condensed milk, cream, sugar, palm oil, salt, guar gum. carrageenan, locust bean gum, potassium sorbate (preservative), artificial flavor.   Share equipment with items that may contain peanuts, tree nuts, egg.  CONTAINS MILK, SOY. GLUTEN FREE.     The product is sold in a box of 6 cellophane bags with 8 bites in each bag.  Four are wrapped in red and 4 in silver foil.
Date Codes:  EJ29 thru EJ31 and EK01 thru EK18
Abdallah Candies is recalling red and silver foil wrapped Holiday Caramel Bites.  One customer reported finding a Peanut Butter Bite wrapped in red foil in a bag of Holiday Caramel Bites.
Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc.   Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
Worldwide Distribution -- US (nationwide) and to countries of: Canada, South America, EU, Asia Pacific, Africa, and Middle East.
Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional  - 0100071 Alere INRatio PT/INR Test Strips, Box of 12  - 0100139 Alere INRatio PT/INR Test Strips, Box of 48    The test strips are packaged in individually pouched test strips in a labeled box with 12 or 48 test strips per box.    In vitro diagnostic system that provides a quantitative prothrombin time result, expressed in seconds and as an International normalized ratio (INR).
All lots of part numbers: 0100071 and 0100139.
77,342 units (12 test strips/box) and 308,947 units (48 test strips/box)
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is clinically significantly lower than a obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Worldwide Distribution -- US, Canada, South America, EU, Asia Pacific, Africa, and Middle East.
INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional  - 0100007 INRatio Prothrombin Time (PT) Monitoring System  - 0100137 Alere INRatio Replacement Monitor    The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card.  None of the components, except for the lancets, are sterile.    In vitro diagnostic monitoring system used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System  - 0200432 Alere INRatio 2 PT/INR Home Monitoring System  - 0200433 Alere INRatio 2 PT/INR Home Monitoring System  - 0200457 Alere INRatio 2 Replacement Monitor  - 55112 Alere INRatio 2 Replacement Monitor  - 55131 Alere INRatio 2 Replacement Monitor  - 55128A Alere INRatio 2 PT/INR Professional Monitoring System    The test systems contain individually packaged components needed to use the product, such as a monitor, user guide, quick reference guide training DVD or CD, Lancets (home monitoring kits contain an Autolet, Unilet, gauze pads, and alcohol wipes), power supply (home monitoring kits contain AA batteries), results log book and a warranty card.  None of the components, except for the lancets, are sterile.    Intended for in vitro diagnostic use for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals and home users.
In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions. It can also occur if the instructions in the labeling for performing the test are not followed.
Orthovita, Inc., dBA Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch  2110-0506 Diamond Needle, 11 gauge x 4 inch  2110-0529 Diamond Needle, 11 gauge x 6 inch    Intended Use: Can be used in either direct (or open) and percutaneous (or deep) delivery of bone cement.
all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Catalog No.:   2110-0505, 2110-0506, 2110-0524, 2110-0529.
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle.
Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers:  2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch  2090-0029 Needle (bullet-tip), 8 gauge x 6 inch  2090-0047 Needle (bullet-tip), 8 gauge x 8 inch  2090-0030 Needle (bullet-tip), Fenestrated, 8 gauge x 6 inch    intended for use to aspirate bone marrow or autologous blood.
all lots of the Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Catalog No.:   2090-0027, 2090-0028, 2090-0029, 2090-0030, 2090-0047
There is the potential for a breach in the inner or outer packaging pouches of all lots of the Imbibe Bone Marrow Aspiration Needle.
Love & Beauty Lavender Anti-aging Eye Mask, 900 units/case Batch Code(s): Last four digits: 4660
Diamond Wipes International is recalling Love and Beauty Lavender Anti-aging Eye Mask due to contamination with mold
Worldwide Distribution - USA including Alabama, Alaska, Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, and Virginia and Internationally to Canada, China, Greece, Indonesia, Republic of Korea, Romania, Russian Federation, Taiwan, and Viet Nam.
Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room staff.
STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
Taylor Farms Pacific Inc. (MacArthur Facility)
Citizen Chef Organic Superfood Salad- 4 Organic Salads. Power Greens, Walnuts, Feta, Dried Cranberries and Blueberries with Pomegranate Vinaigrette.  Net Wt. 4.5 oz. (142g)  USDA Organic  UPC 30233 20009    Taylor Farms Pacific  Stockton, CA. 95376
Undeclared Milk on individual units, outer packaging is labeled correctly.
HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets due to the presence of small  aluminum particles.
Gabapentin Capsules, USP, 400 mg, Rx Only, a) 100 capsules per bottle, NDC 14550-513-02, b) 500 Capsules per bottle, NDC 45963-557-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.
Failed Capsule/Tablet Specifications: Actavis has received several complaint for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.
Gabapentin Capsules, USP, 300 mg, Rx Only, 100 capsules per bottle, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA, NDC 45963-556-11
Gabapentin Capsules, USP, 100 mg, Rx Only, a) 100 capsules per bottle, NDC 45963-555-11, b) 500 Capsules per bottle, NDC 45963-555-50, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Plot No 101, 102, 107, & 108, SIDCO Pharmaceutical Complex, Alathurt, Kanchipuram Dist-603 110, Tamlinadu, India, Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.
Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
Potential use error when the external Gate Controller is turned ON after the Vision RT software has been opened.
CT, DE, FL, GA, IL, LA, MA, MN, NC, NH, NJ, NY, PA, RI, TN, TX and VA.
Vintage Pure Bee Flower Honey, Net Weight 16.4 oz (465g), Packaged in a Glass Jar, Product of Turkey, Imported by: Vintage Food Corp., 849 Newark Tpke, Kearny, NJ 07032, USA, UPC 603608629903
Product contains higher than recommended levels of sulfamethazine.
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
CATALOG NO. : ATTUNE INTUITION Impactors  Fixed Tibial Bearing, (254401003)   Barcode GTIN Number:   Fixed Tibial Bearing, ......... 10603295130192     ALL LOTS
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
CATALOG NO. : ATTUNE INTUITION Impactors  Rotating Tibial Platform, (254401004)   Barcode GTIN Number:   Rotating Tibial Platform, ......... 10603295130208   ALL LOTS
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
CATALOG NO. : ATTUNE INTUITION Impactors  Femoral Impactor, (254401006)   Barcode GTIN Number:   Femoral Impactor, 10603295130222    ALL LOTS
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.
Worldwide Distribution: US (nationwide) including states of: AZ, CA, CO, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MT, NC, NV, NY, OH, PA, TN, TX, VA, WA, and WI; and countries of: Canada, Australia, Austria, Belgium, Czech Republic, France, Germany, India, Israel, Italy, Japan, Malaysia, Russia, South Africa, Switzerland, and  United Kingdom.
I.M. Hole Locator Instrument.  Orthopedic manual surgical instrument.       The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.
Use of excessive force when impacting may lead to intra-operative femoral fracture.
Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.
Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
CMP Kit code: CHT900 Lot numbers: 2014061950 and 2014070750  Expiration date, both lots: 2016-03
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Nerve Block Tray (Nerve Block convenience kit)
Diagnostic Imaging Tray (General Surgery convenience kit)
CMP Kit code: MNS2955 Lot numbers: 2014061250  Expiration date: 2015-11   Expiration date lot 2014071750: 2016-03
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
CMP Kit code: OR1955 Lot numbers: 2014061850  Expiration date: 2016-03   Expiration date lot 2014071750: 2016-03
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
McKesson Cardiology ECG Management   It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Software error discovered in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL  35811
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL  60045, NDC 0409-7984-11
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.