The Recall Desk

Archive

September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical
91
Severe
146
High
349
Moderate
125
Low
23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 20% are Severe.

501–600 of 734

  • HighNHTSA·16V664000·2016-09-14

    Thomas Built Buses Saf-T-Liner C2 Recall for Brake Indicator Error

    Daimler Trucks is recalling 2016-2017 Thomas Built Buses Saf-T-Liner C2 school buses because the brake malfunction light may display "PARK" instead of "BRAKE," increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V666000·2016-09-14

    Freightliner Trucks Recalled for Incorrect Brake Malfunction Indicator Label

    Daimler Trucks is recalling 2016-2017 Freightliner trucks because the brake malfunction light may display 'PARK' instead of 'BRAKE', potentially hiding a braking issue.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC BUSINESS CLASS M2, S2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2057-2016·2016-09-14

    Maga White Whole Grain Pancakes Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling Maga White Whole Grain Pancakes in Puerto Rico because the product contains soy lecithin, an undeclared allergen.

    Product
    Product label reads in part: "Maga PANCAKES INTEGRAL BLANCO***WHITE WHOLE GRAIN PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2055-2016·2016-09-14

    Oatmeal Pancake Mix Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling Maga Oatmeal Pancakes due to undeclared soy lecithin. The product was distributed in Puerto Rico.

    Product
    Product label reads in part: "Maga PANCAKES DE AVENA***OATMEAL PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2066-2016·2016-09-14

    Nature Made Adult Gummies Multi Recalled for Possible Salmonella Contamination

    Pharmavite is recalling specific lots of Nature Made adult gummies Multi due to possible Salmonella contamination. Consumers should check lot numbers and expiration dates.

    Product
    Nature Made(R) adult gummies Multi, 150 count, UPC 0-31604-04172-4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2063-2016·2016-09-14

    Almojabanas Rice and Wheat Flour Fritter Mix Recalled for Undeclared Soy

    Productos La Finca, Inc. is recalling Almojabanas Rice and Wheat Flour Fritter Mix because it contains undeclared soy lecithin.

    Product
    Product label reads in part: "Maga***ALMOJABANAS***RICE AND WHEAT FLOUR FRITTER MIX***Peso Neto/Net Weight 6 oz (171gr)***Productos La Finca, Inc.*** Zona Industrial Machuchal***Avenida Quilinchini #61***Sabana Grande, PR 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2058-2016·2016-09-14

    Productos La Finca Coconut Pancakes Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling specific lots of coconut pancakes because they contain undeclared soy lecithin.

    Product
    Product label reads in part: "Maga PANCAKES COCO***COCONUT PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2064-2016·2016-09-14

    Bakery Express Recalls 7-Eleven Walnut Fudge Brownies for Undeclared Allergen

    Bakery Express is recalling 7-Eleven Fresh To Go Walnut Fudge Brownies due to an undeclared walnut allergen caused by incorrect labeling.

    Product
    7-Eleven, Fresh To Go, Walnut Fudge Brownie Net weight: 3.8 Ounces, Number of units per package: One Shelf life: Three Days Expiration date: 0708 (July 8, 2016)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2056-2016·2016-09-14

    Maga Pancakes Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling Maga Pancakes Cinnamon Brown Sugar in Puerto Rico due to an undeclared soy allergen.

    Product
    Product label reads in part: "Maga PANCAKES CINNAMON BROWN SUGAR***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2099-2016·2016-09-14

    Dannon Recalls Activia Fiber Yogurt Due to Incorrect Gluten-Free Labeling

    The Dannon Company is recalling Activia FIBER Lowfat Yogurt because the packaging displays a Certified Gluten-Free mark despite containing wheat.

    Product
    Activia FIBER Lowfat Yogurt Strawberry/Pineapple Flavors 12 Packs of 4 OZ Cups UPC 3663202884 packaged in form fill seal plastic cups
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-2729-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2700-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 77 Advance II Modular Tibial Bases because they are experiencing higher than expected revision rates due to component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2761-2016·2016-09-14

    Riverpoint Medical Recalls Nylon Surgical Sutures Due to Seal Integrity Issues

    Riverpoint Medical is recalling sterile nylon surgical sutures because the seals may become open during distribution or packaging.

    Product
    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, oph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2750-2016·2016-09-14

    Hill-Rom Recalls 94 Affinity Four Birthing Beds Due to Defect

    Hill-Rom is voluntarily recalling 94 Affinity Four Birthing Beds (Model P3700) distributed in the US and abroad. The recall was initiated by the firm.

    Product
    Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. Th
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2714-2016·2016-09-14

    Best Sanitizers Recalls Acecide-C High Level Disinfectant Due to Acid Degradation

    Best Sanitizers Inc is recalling specific lots of Acecide-C High Level Disinfectant & Sterilant because the acid solution is degrading faster than normal.

    Product
    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2725-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pump Systems because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microproc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2749-2016·2016-09-14

    Boston Scientific Recalls Five Unapproved MRI Pacemakers

    Boston Scientific is recalling five implanted pacemakers that used an unapproved module configuration. The devices were shipped to customers in five states.

    Product
    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2098-2016·2016-09-14

    McCain Foods Recalls Fire Roasted Poblano and Jalapeno Popper Bites

    McCain Foods USA is recalling Fire Roasted Poblano & Jalapeno popper bites because the flour used was contaminated with E. Coli O121.

    Product
    Fire roasted Poblano & Jalapeno popper bites packaged in a white box with black lettering. The product is labeled in part: Canchor Poppers Fire Roasted & Jalapeno popper bites, 2-4 lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2080-2016·2016-09-14

    Lysander's Spicy Bourbon Rub Recalled for Undeclared Soy and Wheat Allergens

    Geneva Foods is recalling Lysander's All Natural Spicy Bourbon Flavor Rub because it contains undeclared soy and wheat allergens and does not declare sulfites.

    Product
    Lysander's All Natural Spicy Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g) foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V661000·2016-09-14

    Honda Recalls 2014-2015 Grom and NSS300 Motorcycles for Fuel Pump Defect

    Honda is recalling 2014-2015 Grom 125 and NSS300 motorcycles because a resin bracket in the fuel pump may swell and seize, causing the engine to stall and increasing crash risk.

    Product
    HONDA — HONDA GROM125, NSS300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2016·2016-09-14

    Philips BrightView XCT Upgrade Recalled for Potential Patient Contact

    Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Upgrade Model 882454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2016·2016-09-14

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2751-2016·2016-09-14

    Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency

    Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.

    Product
    Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-2061-2016·2016-09-14

    Maga Cocoa Pancake Mix Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling 153 boxes of Maga Cocoa Pancake Mix because the product contains soy lecithin, an undeclared allergen.

    Product
    Product label reads in part: "Maga PANCAKES COCOA***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2072-2016·2016-09-14

    Nature Made Super B-Complex Recalled for Possible Bacterial Contamination

    Pharmavite is recalling Nature Made Super B-Complex supplements due to possible Staphylococcus aureus and Salmonella contamination in specific lots.

    Product
    Nature Made (R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 360 count, UPC 0-31604-02729-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2097-2016·2016-09-14

    McCain Breaded Stuffed Jalapeno Poppers Recalled for E. Coli O121 Contamination

    McCain Foods USA is recalling breaded stuffed jalapeno poppers because the flour used in the product was contaminated with E. Coli O121.

    Product
    Breaded stuffed Jalapenos poppers labeled in part: Anchor breaded Fiesta Bold Poppers, breaded stuffed jalapenos, keep frozen. The product is packaged in a green 4 lb. box with white, green and orange lettering.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2067-2016·2016-09-14

    Nature Made Multi + Omega-3 Recalled for Possible Salmonella Contamination

    Pharmavite is recalling specific lots of Nature Made Multi + Omega-3 supplements due to possible Salmonella contamination. Consumers should stop using the affected products.

    Product
    Nature Made(R) Multi + Omega-3, 150 count, UPC 0-31604-04173-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2081-2016·2016-09-14

    Lysander's Bourbon Flavor Rub Recalled for Undeclared Allergens

    Geneva Foods is recalling Lysander's All Natural Bourbon Flavor Rub because it contains undeclared soy, wheat, and sulfites.

    Product
    Lysander's All Natural Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g), foil bag, 6 units per case. Manufactured by Geneva Foods, LLC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2053-2016·2016-09-14

    Maga Pancake and Waffle Mix Recalled for Undeclared Soy Lecithin

    Productos La Finca, Inc. is recalling Maga Pancake and Waffle Mix because the product contains soy lecithin, an allergen not listed on the label.

    Product
    Product label reads in part: "Maga PANCAKES EL ORIGINAL***PANCAKE & WAFFLE MIX***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2054-2016·2016-09-14

    Cornmeal Pancakes Recalled for Undeclared Soy Allergen

    Productos La Finca, Inc. is recalling 16 oz cornmeal pancake canisters for containing undeclared soy lecithin. The product was distributed in Puerto Rico.

    Product
    Product label reads in part: "Maga PANCAKES DE MAIZ***CORNMEAL PANCAKES***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1484-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Tablets

    Amerisource Health Services is recalling 867 cartons of 20 mg amphetamine tablets due to unit dose blister cavities containing more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 20 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1486-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 834 cartons of amphetamine extended-release capsules because blister cavities may contain more than one tablet or capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 10 mg 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health P
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1483-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

    Amerisource Health Services is recalling 1,416 cartons of 15 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1485-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Dosing Errors

    Amerisource Health Services is recalling 156 cartons of 30 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 30 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Hyperbaric Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruptions.

    Product
    Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, micro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2723-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2016·2016-09-14

    Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage

    Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.

    Product
    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2694-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases because of a higher-than-expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2734-2016·2016-09-14

    Omega Medical Imaging Recalls Elevating Monitor Suspension Systems

    Omega Medical Imaging is recalling 26 Elevating Monitor Suspension Systems because the suspension may separate from the lifting column bracket.

    Product
    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2765-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage

    Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16262·2016-09-14

    Zeagle Buoyancy Control Devices Recalled for Drowning Hazard

    Huish Outdoors is recalling Zeagle Grace and Element BCDs because they may leak air, causing loss of flotation and posing a drowning risk to scuba divers.

    Product
    Zeagle brand buoyancy control devices (BCDs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2016·2016-09-14

    ArjoHuntleigh Sara Combilizer Recalled for Potential Tipping Hazard

    ArjoHuntleigh is recalling 106 Sara Combilizer patient lifts due to a potential tipping hazard identified during internal testing. No adverse events or customer complaints have been reported to date.

    Product
    ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2760-2016·2016-09-14

    Invivo Xper Flex Cardio Patient Monitoring System Recalled for Frozen Display

    Invivo Corporation is recalling Xper Flex Cardio Patient Monitoring Systems because SpO2 and NIBP measurements may freeze on the display.

    Product
    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2016·2016-09-14

    Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise

    Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.

    Product
    Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2016·2016-09-14

    Siemens e.cam and Symbia E Gamma Camera Patient Bed Recall

    Siemens is recalling e.cam and Symbia E gamma camera systems because patient hair can become caught in the patient bed drive mechanism.

    Product
    e.cam and Symbia E gamma camera systems with patient beds 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 588 keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2724-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and delay or interrupt therapy.

    Product
    Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2016·2016-09-14

    Hospira Recalls Plum A+ Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+ Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2016·2016-09-14

    Smith & Nephew Whipknot Soft Tissue Cinch Suture Recalled for Sterility Breach

    Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because sterile packaging was breached, compromising sterility. The recall covers 34,065 units distributed worldwide.

    Product
    Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2767-2016·2016-09-14

    Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect

    Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.

    Product
    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular su
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2755-2016·2016-09-14

    Aspen Surgical Recalls Misidentified Stainless Steel Surgical Blades

    Aspen Surgical Puerto Rico Corp. is recalling 6,000 stainless steel surgical blades that were incorrectly labeled as size 12 instead of 12B.

    Product
    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2720-2016·2016-09-14

    ReliaMed Alginate Dressings Recalled for Misplaced Instructions

    Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.

    Product
    ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2744-2016·2016-09-14

    Ecolab Recalls Microtek Angiography Drapes Due to Packaging Defects

    Ecolab is recalling specific Microtek angiography drapes because their sterile packaging may contain small holes in the film, potentially compromising sterility.

    Product
    Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2756-2016·2016-09-14

    Sorin Aortic Arch Cannula Recalled for Improper Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.

    Product
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flex
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2757-2016·2016-09-14

    Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect

    Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.

    Product
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2077-2016·2016-09-14

    Nature Made Vitamin D Tablets Recalled for Yeast and Mold

    Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.

    Product
    Nature Made(R) D3 1000IU, 125 count, UPC 0-31604-02793-3
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2741-2016·2016-09-14

    Arrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits due to a shipping carton labeling error. The kits were distributed to Ohio, Indiana, Tennessee, North Carolina, and Kentucky.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2103-2016·2016-09-14

    Inland Seafood Recalls Cheese Spread for Possible Wood Contamination

    Inland Seafood, Inc. is recalling Original Seafood Cheese Spread for Publix due to possible contamination with wood pieces.

    Product
    Original Seafood Cheese Spread, Net Wt. 7 oz. (198 g.), for Publix
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1494-2016·2016-09-14

    Teva Recalls Argatroban Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2743-2016·2016-09-14

    Integra Recalls Achillon Suture System Due to Sterility Concerns

    Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.

    Product
    Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1491-2016·2016-09-14

    Zydus Recalls Bromocriptine Mesylate Capsules Due to Stability Test Failures

    Zydus Pharmaceuticals is recalling 14,808 bottles of Bromocriptine Mesylate 5 mg capsules because stability samples failed impurity tests.

    Product
    BROMOCRIPTINE MESYLATE — BROMOCRIPTINE MESYLATE (BROMOCRIPTINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2073-2016·2016-09-14

    Nature Made Hair Skin Nails Gummies Recalled for Microbial Count

    Pharmavite is recalling specific lots of Nature Made adult gummies Hair.Skin.Nails because they may exceed specifications for total viable plate count.

    Product
    Nature Made(R) adult gummies Hair.Skin.Nails, 90 count, UPC 0-31604-04016-1
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2739-2016·2016-09-14

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk

    GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.

    Product
    Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2096-2016·2016-09-14

    Ricker Hill Orchards Cran-Breeze Recalled for High Patulin Levels

    Ricker Hill Orchards is recalling Cran-Breeze juice because it contains patulin levels above the FDA limit of 50 ppb.

    Product
    Ricker Hill Orchards Cran-Breeze, 1/2 GAL (64 FL OZ) 1.89 LITERS Produced by Ricker Hill Orchards, Turner, ME 04282
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1490-2016·2016-09-14

    Amerisource Recalls Mispackaged Adderall XR 30 mg Extended-Release Capsules

    Amerisource Health Services is recalling 761 cartons of Adderall XR 30 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 30 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2105-2016·2016-09-14

    Inland Seafood Recalls Alaskan Salmon Salad Due to Wood Contamination

    Inland Seafood, Inc. is recalling Alaskan Salmon Salad sold at Whole Foods Market due to possible contamination with wood pieces.

    Product
    Alaskan Salmon Salad, 12 x 8 oz. and 5 lb., for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-2101-2016·2016-09-14

    Inland Market Blue Crab Spread Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Premium Blue Crab Spread due to possible contamination with wood pieces.

    Product
    Inland Market, Premium Blue Crab Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2747-2016·2016-09-14

    Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up

    Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.

    Product
    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2016·2016-09-14

    Blackrock NeuroPort Biopotential Signal Processing System Recall for Labeling Error

    Blackrock Microsystems is recalling 81 Neural Signal Amplifiers because the device and patient cable are incorrectly labeled as Type CF Applied Parts.

    Product
    Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: El
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2759-2016·2016-09-14

    Teleflex Horizon Manual-Load Ligating Clip Applier Recalled for Incorrect Etching

    Teleflex Medical is recalling 49 units of Horizon Manual-Load Ligating Clip Appliers due to incorrect etching on the device.

    Product
    WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2078-2016·2016-09-14

    Nature Made Vitamin D Tablets Recalled for Yeast and Mold

    Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.

    Product
    Nature Made(R) D3 1000IU, 350 count, UPC 0-31604-04070-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2748-2016·2016-09-14

    Mentor CPX4 Breast Tissue Expanders Recalled for Product Mix-Up

    Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.

    Product
    MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2109-2016·2016-09-14

    Inland Market Dungeness Crab Cake Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Dungeness Crab Cake due to possible contamination with wood pieces.

    Product
    Inland Market, Dungeness Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1497-2016·2016-09-14

    Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

    Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1488-2016·2016-09-14

    Amerisource Recalls Mispackaged Adderall XR 20 mg Extended-Release Capsules

    Amerisource Health Services is recalling 666 cartons of Adderall XR 20 mg capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, CII 20 mg, 30 UD Capsules (5 x 6), Rx, Packaged and Distributed by: American Health
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2102-2016·2016-09-14

    Inland Market Maine Lobster Spread Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Maine Lobster Spread due to possible contamination with wood pieces.

    Product
    Inland Market, Premium, Maine Lobster Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2762-2016·2016-09-14

    Riverpoint Medical Recalls Webglo Polypropylene Surgical Sutures Due to Seal Issues

    Riverpoint Medical is recalling specific lots of Webglo polypropylene surgical sutures because the seals may open during distribution or packaging.

    Product
    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1481-2016·2016-09-14

    Amerisource Recalls Mispackaged Dextroamphetamine and Amphetamine Tablets

    Amerisource Health Services is recalling 221 cartons of mixed amphetamine tablets due to unit dose mispackaging, where blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2074-2016·2016-09-14

    Nature Made Hair Skin Nails Gummies Recalled for Microbial Count

    Pharmavite is recalling specific lots of Nature Made adult gummies Hair.Skin.Nails because they may exceed specifications for total viable plate count.

    Product
    Nature Made(R) adult gummies Hair.Skin.Nails, 150 count, UPC 0-31604-04132-8-1
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2095-2016·2016-09-14

    Ricker Hill Orchards Apple Cider Recalled for Patulin Levels

    Ricker Hill Orchards is recalling specific apple cider products because they contain patulin at levels higher than the FDA established limit of 50 ppb.

    Product
    Apple Cider: Ricker Hill Orchards Apple Cider 1/2 GAL (64 FL OZ) 1.89 LITERS; NORTHLAND APPLES Pure SWEET MAINE CIDER 1 QUART 947.2ML, UPC: 074613 70009 1 and NORTHLAND APPLES Pure SWEET MAINE CIDER 12 FL. OZ. 355.2 ML, UPC: 0 74613 60009
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2076-2016·2016-09-14

    Nature Made Vitamin D Tablets Recalled for Potential Yeast and Mold

    Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.

    Product
    Nature Made(R) D3 1000IU, 300 count, UPC 0-31604-02683-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2111-2016·2016-09-14

    Inland Market Maryland Crab Cake Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Maryland Crab Cake due to possible contamination with wood pieces.

    Product
    Inland Market, Maryland Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1480-2016·2016-09-14

    Isomeric Pharmacy Recalls Methylprednisolone Acetate/Lidocaine Injection Due to Sterilization Issue

    Isomeric Pharmacy Solution, LLC is recalling Methylprednisolone Acetate/Lidocaine HCl Injection because excessive sterilization time may cause difficulty resuspending particles.

    Product
    Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2752-2016·2016-09-14

    Zimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts

    Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.

    Product
    Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the o
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Food)·F-2110-2016·2016-09-14

    Inland Market Traditional Crab Cake Recalled for Wood Contamination

    Inland Seafood, Inc. is recalling Inland Market Traditional Crab Cake due to possible contamination with wood pieces.

    Product
    Inland Market, Traditional Crab Cake, Net Wt. 5 lbs, Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083, for Whole Foods Market
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2742-2016·2016-09-14

    Siemens ADVIA Centaur PSA Assay Recall for Clinical Interpretation Clarification

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits to emphasize that PSA values must be interpreted according to current clinical guidelines for biochemical recurrence.

    Product
    ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2754-2016·2016-09-14

    Anthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure

    Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed the firm failed to validate the design and process of the devices.

    Product
    Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters an
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2764-2016·2016-09-14

    Blackrock NeuroPort Patient Cables Recalled for Incorrect Labeling

    Blackrock Microsystems is voluntarily recalling 120 Patient Cables because they are incorrectly labeled as Type CF Applied Parts.

    Product
    Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2075-2016·2016-09-14

    Nature Made Vitamin D tablets recalled for yeast and mold

    Pharmavite is recalling specific lots of Nature Made Vitamin D tablets because they may exceed specifications for yeast and mold.

    Product
    Nature Made(R) D3 1000IU, 100 count, UPC 0-31604-01870-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1496-2016·2016-09-14

    Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1493-2016·2016-09-14

    Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2753-2016·2016-09-14

    Anthogyr Axiom REG Dental Implants Recalled for Design Validation Failure

    Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.

    Product
    Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and
    Category
    Medical Device
    Distribution
    3 states

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