The Recall Desk

Archive

December 2019 recalls

567 recalls were announced in December 2019.

What the numbers show

Critical
45
Severe
158
High
184
Moderate
159
Low
21

Of the 567 recalls this month scored against our rubric, 8% are Critical, 28% are Severe.

401–500 of 567

  • HighFDA (Devices)·Z-0595-2020·2019-12-11

    Zimmer Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Sizing Error

    Zimmer Biomet is recalling 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.

    Product
    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0550-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride Preservative Free, 100 mL in 150 Bag, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1104-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0447-2020·2019-12-11

    Northern Fisheries Recalls Tuna Products Due to Elevated Histamine Levels

    Northern Fisheries Ltd. is voluntarily recalling specific tuna products due to potentially elevated histamine levels. The recall covers Tuna Saku, tuna medallions, and tuna steaks.

    Product
    Tuna King Tuna Saku 12-16oz 1x10lb Production date 06/13/2019 Expiration: 06/13/2021 UPC: 815838022267 Lot: 0058801
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-0566-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl syringes because they may contain glass particulate matter.

    Product
    fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1415-47
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2020·2019-12-11

    Steris Evolution Loading Car and Transfer Carriage Recall for Locking Pin Defect

    Steris Corporation is recalling 237 Evolution Loading Cars and Transfer Carriages because a locking pin defect may cause the equipment to fall forward unexpectedly.

    Product
    Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2020·2019-12-11

    Allergan Recalls XEN Gel Stent Due to Residual Polishing Compounds

    Allergan is recalling XEN Gel Stent implants because residual polishing compounds on the injector needle may transfer to the patient's eye, causing irritation or inflammation.

    Product
    XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0560-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Syringes Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.

    Product
    fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1098-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·19V876000·2019-12-11

    Toyota Recalls 2019 Prius Vehicles Due to Electrical Short Circuit Risk

    Toyota is recalling 2019 Prius vehicles because an electrical short circuit in the combination meter could cause the speedometer, odometer, and fuel gauge to go blank, increasing crash risk.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0207-2020·2019-12-11

    Amazon Meal Kit Veggie Quinoa Bowl Recalled for Listeria Contamination

    Amazon is recalling 23 kits of Veggie Quinoa Bowl with Spiced Garbanzo Beans due to potential Listeria monocytogenes contamination.

    Product
    Amazon Meal Kit Veggie Quinoa Bowl with Spiced Garbanzo Beans, Net weight: 3 pounds 2 ounces. UPC: 842379110078. Amazon Meal Kit Veggie Quinoa Bowl with Spiced Garbanzo Beans contains a recipe card that includes cooking instructions.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0224-2020·2019-12-11

    Givaudan Recalls Cashew Flavor Product Due to Metal Contamination

    Givaudan Flavours Corp is recalling Nat Cashew Flavor Type because metal material was found in a raw ingredient used during production.

    Product
    Nat Cashew Flavor Type, 11.34 kg in each 4.2 gallon blue HDPE jerri-can, UPC: 20355428593
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0344-2020·2019-12-11

    Lamb Weston Crispy Hash Brown Dices Recalled for Hard Rubber Contamination

    Lamb Weston is recalling Crispy Hash Brown Dices because the product may contain pieces of hard rubber material.

    Product
    Lamb Weston Grown In Idaho Crispy Hash Brown Dices, packaged in 28 ounce poly retail bags, 6 or 12 bags packaged in a master case. UPC: 0 43301 61170 4. The retail bag has the cooking instructions. Item #36003, Lamb Weston Grown in Idaho Crispy Hash Brown Dices, net wt. 21 l
    Category
    Food
    Distribution
    15 states
  • HighCPSC·20039·2019-12-11

    Profile Design Recalls Carbon Aerobars Due to Crash Hazard

    Profile Design is recalling Aeria Ultimate carbon aerobars because they can crack and break, causing riders to lose control and crash.

    Product
    Aeria Ultimate carbon aerobars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0555-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusions Due to Glass Particulate Matter

    QuVa Pharma is recalling fentanyl 10 mcg/mL infusion bags nationwide due to the potential presence of glass particulate matter.

    Product
    fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1092-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0208-2020·2019-12-11

    Fortune Fish & Gourmet Recalls Fresh Atlantic Salmon for Listeria Risk

    Fortune Fish & Gourmet is recalling fresh Atlantic salmon that may be contaminated with Listeria monocytogenes. The product was sold in retail and foodservice locations in eight states.

    Product
    Fortune Fish & Gourmet fresh Atlantic salmon, whole, filleted, and filleted without belly sold by weight in cardboard box with ice
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0205-2020·2019-12-11

    Amazon Recalls Vegan Hummus Dip Due to Listeria Risk

    Amazon is recalling 491 units of Go Vegan Hummus Veggies in Washington due to potential Listeria monocytogenes contamination.

    Product
    Amazon Go Vegan Hummus Veggies - Hummus Dip with Veggies, Net weight: 6.2 ounces. UPC: 8 42379 12606 2.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0533-2020·2019-12-11

    Fagron Recalls LETS GEL Kits Due to Microbial Contamination

    Fagron, Inc. is recalling 11,912 kits of LETS GEL Convenience Packs due to microbial contamination of the non-sterile product.

    Product
    LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0557-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Bupivacaine Injection Due to Particulate Matter

    QuVa Pharma is recalling fentanyl and bupivacaine injection products due to the presence of particulate matter, specifically potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL) in 0.9% Sodium Chloride, 100 mL CADD Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1202-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2020·2019-12-11

    Zimmer Biomet Recalls 13MM Intramedullary Bone Saw Cam Assemblies

    Zimmer Biomet is recalling 26 units of 13MM Intramedullary Bone Saw Cam Assemblies due to possible commingling with 14MM units.

    Product
    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0225-2020·2019-12-11

    Givaudan Recalls Nat Bacon Flavor Due to Metal Contamination

    Givaudan Flavours Corp is recalling Nat Bacon (smoky) Flavor WONF because metal material was found in a raw ingredient used during production.

    Product
    Nat Bacon (smoky) Flavor WONF, 45kg in each 15 gallon blue HDPE drum, UPC: 20356152609
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0204-2020·2019-12-11

    GH Imports Recalls Minced Onion Due to Metal Filament

    GH Imports, Inc. is recalling 1,020 cartons of minced onion from China due to a reported metal filament. The product was distributed only in Puerto Rico.

    Product
    Onion Minced: 16-40 Mesh, Net Weight: 24/kg/52.91lbs, Manufacturing Date: May, 2019, Country of Origin: China, Manufactured for GH Imports Inc.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0548-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl and Ropivacaine Infusions Due to Particulate Matter

    QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the presence of particulate matter, including potential glass particles.

    Product
    fentaNYL 200 mcg/100 mL (2 mcg/mL) ROPivacaine HCl 0.2% 200 mg/100 mL (2 mg/mL) in 0.9% Sodium Chloride 100 mL CADD, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478NDC 70092-1259-75
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0553-2020·2019-12-11

    QuVa Pharma Recalls Fentanyl Infusion Bags Due to Glass Particulates

    QuVa Pharma is recalling fentanyl infusion bags because they may contain glass particulates. The affected product is distributed nationwide.

    Product
    fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Preservative Free, Rx, QuVA Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 NDC 70092-1093-37
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2020·2019-12-11

    Stryker Recalls Disposable Tourniquet Cuffs Due to Air Leak Risk

    Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.

    Product
    Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the tempo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0604-2020·2019-12-11

    Steris Eagle 3000 Sterilizer Recall Due to Incorrect Safety Valve

    Steris is recalling 236 Eagle 3000 Small Steam Sterilizers because the preventive maintenance kit may contain an incorrect pressure safety valve.

    Product
    Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0597-2020·2019-12-11

    NDDd EasyOne Pro LAB VOS Pulmonary Function Testing Device Recall

    NDDd Medical Technologies is recalling 37 EasyOne Pro LAB VOS devices due to potential non-compliance with electromagnetic shielding standards.

    Product
    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0591-2020·2019-12-11

    Brasseler Twist Drills Recalled Due to Incorrect Laser Etching

    Brasseler USA is recalling 387 units of 3.5 mm twist drills that were incorrectly laser etched as 2.5 mm.

    Product
    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0446-2020·2019-12-11

    Northern Fisheries Recalls Tuna Medallions and Steaks for Histamine Concerns

    Northern Fisheries Ltd. is voluntarily recalling specific tuna products due to potentially elevated levels of histamine.

    Product
    Tuna King 2-3 oz. Tuna Medallions (1 lb. packages) Production date 06/13/2019 Expiration: 06/13/2021 UPC: 815838020638 Lot: 0058797
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-0445-2020·2019-12-11

    Northern Fisheries Recalls Tuna Steaks and Medallions for Histamine Concerns

    Northern Fisheries Ltd. is voluntarily recalling specific lots of frozen tuna products due to potentially elevated histamine levels.

    Product
    Tuna King 4 oz. and 6 oz. Tuna Steaks (frozen) Production date 06/13/2019 Expiration: 06/13/2021 4 oz. UPC 815838020645, lot 0058798; 6 oz. UPC 815838020652, lot 0058799
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0609-2020·2019-12-11

    AuroMedics Recalls Fluphenazine Decanoate Injection Due to Discoloration

    AuroMedics Pharma LLC is recalling Fluphenazine Decanoate Injection due to discoloration and haziness found in one vial.

    Product
    Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0603-2020·2019-12-11

    Miami Device Solutions Recalls Right Proximal Humerus Plates Due to Identification Error

    Miami Device Solutions is recalling 15 units of Right Proximal Humerus Plates because they may be improperly identified as left.

    Product
    Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0621-2020·2019-12-11

    Pacira Recalls Sub-Potent Exparel Bupivacaine Injectable Vials

    Pacira Pharmaceuticals is recalling 910 vials of Exparel (Bupivacaine) because the drug was found to be sub-potent and out of specification.

    Product
    EXPAREL — EXPAREL (BUPIVACAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0596-2020·2019-12-11

    NDDd Medical Technologies Recalls EasyOne Pro Pulmonary Function Testing Devices

    NDDd Medical Technologies is recalling 37 EasyOne Pro Respiratory Analysis Systems because the CO/CO2 sensor cable harness may have insufficient electromagnetic shielding.

    Product
    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Devices)·Z-0606-2020·2019-12-11

    Theralase TLC-2000 Laser System Recalled for Missing UDI Labels

    Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.

    Product
    TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0607-2020·2019-12-11

    Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark

    Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.

    Product
    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V874000·2019-12-10

    Spartan Emergency Response Vehicles Recalled for Brake Valve Defect

    Marion Body Works is recalling 2018-2019 Spartan Gladiator and Metro Star emergency response chassis because a brake relay valve defect may cause extended stopping distances.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·119-2019·2019-12-10

    Ruiz Recalls Frozen Breakfast Burritos Due to Plastic Contamination

    Ruiz Food Products is recalling approximately 55,013 pounds of frozen breakfast burritos that may contain pieces of plastic. No injuries have been reported.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls Frozen Sausage Breakfast Burrito Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·20038·2019-12-10

    Bass Pro Recalls MR. STEAK Gas Grills Due to Fire Hazard

    Bass Pro is recalling MR. STEAK four and five burner gas grills because the fuel line can melt and cause a fire.

    Product
    MR. STEAK four and five burner gas patio grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V873000·2019-12-10

    Jayco Recalls 2019-2020 White Hawk Travel Trailers Due to Blocked Escape Window

    Jayco is recalling 2019-2020 White Hawk travel trailers because the rear emergency escape window cannot fully open due to a ladder. Owners should contact dealers for a free repair.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V870000·2019-12-09

    ARBOC Specialty Vehicles Recalls Spirit Models for Roof Hatch Handle Defect

    ARBOC Specialty Vehicles is recalling 2017-2019 Spirit of Freedom and Spirit of Mobility vehicles because the roof hatch handle may break, preventing emergency egress.

    Product
    ARBOC SPECIALTY VEHICLES — ARBOC SPECIALTY VEHICLES, ARBOC SPIRIT OF MOBILITY, SPIRIT OF FREEDOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20036·2019-12-06

    Surly Recalls Front Bicycle Racks Due to Crash and Injury Hazards

    Surly Bikes is recalling about 5,139 front bicycle racks because they can loosen and contact the front wheel, posing crash and injury hazards.

    Product
    Surly front bicycle racks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V869000·2019-12-06

    Daimler Recalls 2020-2021 Thomas Built Saf-T-Liner C2 School Buses

    Daimler Trucks North America is recalling 145 school buses due to loose fan hub bolts that could damage components or detach, risking injury during an uncontrolled stop.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·20035·2019-12-06

    Trek Recalls Super Commuter+ Electric Bicycles Due to Fall Hazard

    Trek is recalling about 2,840 Super Commuter+ 8S electric bicycles because a front fender bolt can unthread, causing the wheel to detach and posing a fall hazard.

    Product
    Trek Super Commuter+ 8S
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V866000·2019-12-06

    Volkswagen Recalls 2013-2015 Jetta Hybrid for Transmission Defect

    Volkswagen is recalling 2013-2015 Jetta Hybrid vehicles because hairline cracks in the transmission can cause oil leaks and sudden loss of drive power, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V868000·2019-12-06

    Mercedes-Benz Recalls 2019 AMG E-Class Models for Air Bag Defect

    Mercedes-Benz is recalling 2019 AMG E53, E63, and E63S models because incorrect driver air bags and software may be installed, increasing injury risk in crashes.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG E63S, E63, AMG E53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V867000·2019-12-06

    Mercedes-Benz Recalls 2020 GLE 450 for Third-Row Headrest Defect

    Mercedes-Benz is recalling one 2020 GLE 450 4MATIC because third-row headrests may not hold in place, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V865000·2019-12-05

    Honda Recalls 2019-2020 CR-V for Rear Subframe Bolt Defect

    Honda is recalling 2019-2020 CR-V vehicles because improperly manufactured rear subframe bolts may loosen, allowing the subframe to separate and increasing crash risk.

    Product
    HONDA — HONDA CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20711·2019-12-05

    DaVinci Bailey Bassinets Recalled Due to Support Leg Breakage Hazard

    DaVinci is recalling about 3,000 Bailey bassinets because support legs can break, posing a fall hazard to infants. Consumers should stop using them and contact the company for a repair kit.

    Product
    DaVinci Bailey bassinets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0201-2020·2019-12-04

    Massey Fish Company Smoked Lake Trout Pate Recalled for Listeria

    Massey Fish Company is recalling Smoked Lake Trout Pate because the product tested positive for Listeria monocytogenes.

    Product
    Massey Fish Company Smoked Lake Trout pate in 8oz clear plastic tub
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0200-2020·2019-12-04

    Massey Fish Company Smoked Salmon Pate Recalled for Listeria

    Massey Fish Company is recalling smoked salmon pate tested positive for Listeria monocytogenes. Consumers should not eat the product.

    Product
    Massey Fish Company Smoked salmon pate in 8oz clear plastic tub
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0196-2020·2019-12-04

    North Bay Produce Apples Recalled for Listeria Contamination Risk

    North Bay Produce is recalling various apple varieties due to potential Listeria monocytogenes contamination. The affected apples were distributed to wholesalers and retailers in eight states.

    Product
    North Bay Produce brand McIntosh, Honeycrisp, Jonathan, Fuji, Jonamac and Red Delicious apples sold in 2 lbs and 3 lbs plastic bags, white paper quarter peck bags, half peck clear plastic tote bags, 600lb bulk, and individually from retailers display trays.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0531-2020·2019-12-04

    Ibuprofen Oral Suspension Recalled for Inert Plastic Particles

    Preferred Pharmaceuticals is recalling specific lots of Ibuprofen Oral Suspension USP due to the presence of small particles of inert plastic material.

    Product
    Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0524-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0573-2020·2019-12-04

    AuroMedics Recalls MARLIDO KIT Vials Due to Foreign Material Presence

    AuroMedics Pharma LLC is recalling MARLIDO KIT vials because foreign material was found inside the vials. The affected product is Lidocaine HCl Injection, USP, 2%.

    Product
    MARLIDO KIT — MARLIDO KIT (MARCAINE, LIDOCAINE, POVIDONE IODINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0530-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2020·2019-12-04

    AuroMedics Recalls Ranitidine Tablets Due to NDMA Detection

    AuroMedics Pharma LLC is recalling DG Health Acid Reducer Ranitidine Tablets 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0525-2020·2019-12-04

    AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

    AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0529-2020·2019-12-04

    AuroMedics Recalls Ranitidine Syrup Due to NDMA Contamination

    AuroMedics Pharma LLC is recalling Ranitidine Syrup because N-nitrosodimethylamine (NDMA) has been detected in the product.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V862000·2019-12-04

    Volkswagen Recalls Diesel Vehicles for Air Bag Inflator Defect

    Volkswagen is recalling certain 2011-2015 Golf, Passat, and Audi A3 diesel vehicles because the driver's side air bag inflator may explode.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI PASSAT, GOLF, A3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V860000·2019-12-04

    REV Recalls Fleetwood and Holiday Rambler Motorhomes Due to Exhaust Defect

    REV Recreation Group is recalling 3,241 Fleetwood and Holiday Rambler motorhomes because the generator exhaust pipe placement may allow carbon monoxide to enter the vehicle.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER, BOUNDER, SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V859000·2019-12-04

    Ford Recalls 2020 Explorer and Lincoln Aviator for Fuel Leak Risk

    Ford is recalling 2020 Explorer and Lincoln Aviator vehicles because a chafing fuel line may cause a leak, increasing the risk of fire.

    Product
    FORD — FORD, LINCOLN EXPLORER, AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0523-2020·2019-12-04

    New Vitalis Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

    New Vitalis Pharmacy is recalling Testosterone Cypionate and Propionate oil injection solutions due to a lack of sterility assurance.

    Product
    Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0527-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 150 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0521-2020·2019-12-04

    Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues

    Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0345-2020·2019-12-04

    Fresh Seasons Veggie & Ranch Cup Recalled for Listeria Risk

    Taher, Inc. is recalling Fresh Seasons Veggie & Ranch Cups because they contain cauliflower potentially contaminated with Listeria monocytogenes.

    Product
    Fresh Seasons, Fresh Veggie & Ranch Cup, 7.5 ounces, packaged in a plastic 12 ounce cup
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0528-2020·2019-12-04

    Aurobindo Ranitidine Capsules Recalled for NDMA Contamination

    AuroMedics Pharma LLC is recalling Aurobindo Ranitidine Capsules 300 mg because N-nitrosodimethylamine (NDMA) was detected in the product.

    Product
    Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2020·2019-12-04

    GN Hearing Recalls Behind-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 590 behind-the-Ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2020·2019-12-04

    GN Hearing Recalls In-the-Ear Hearing Aids Due to Software Bug

    GN Hearing is recalling 285 in-the-ear hearing aids because a software bug in a repair tool altered sound amplification specifications, potentially increasing gain.

    Product
    In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2020·2019-12-04

    Zimmer Biomet Recalls 73 Calcar Trimmer Shafts for Mating Failure

    Zimmer Biomet is recalling 73 units of the ASI 2.0 Calcar Trimmer Shaft because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0526-2020·2019-12-04

    Zimmer Biomet Recalls Custom Medical Devices Due to Cleaning Issues

    Zimmer Biomet is recalling various custom medical devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2020·2019-12-04

    Zimmer Biomet Recalls Ball Nose Guide Wires Due to Cleaning Issues

    Zimmer Biomet is recalling Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2020·2019-12-04

    Endotronix Recalls myCordella Patient Kits for Unexpected Power-Downs

    Endotronix is recalling 58 myCordella Patient Kits because the devices have been reported to power down without user interaction.

    Product
    myCordella Patient Kit without ECG, The Cordella System is a comprehensive at-home heart failure management platform that provides the clinician tools to monitor the progression of heart failure.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0527-2020·2019-12-04

    Zimmer Biomet Recalls Copeland HA Resurfacing Heads Due to Cleaning Issues

    Zimmer Biomet is recalling Copeland HA Resurfacing Heads because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling 2.0mm Ball Nose Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2020·2019-12-04

    Zimmer Biomet Recalls HA Pins and Hoffman/Colles Pins Due to Cleaning Issues

    Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2020·2019-12-04

    Siemens Atellica CH 930 Analyzer Recalled for Calibration Error

    Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.

    Product
    Atellica CH 930 Analyzer
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0523-2020·2019-12-04

    Zimmer Biomet Recalls Hip Systems Due to Cleaning Issues

    Zimmer Biomet is recalling various hip arthroplasty systems because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111 21-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2020·2019-12-04

    Boston Scientific Recalls Emerge Monorail PTCA Catheters Due to Coating Defect

    Boston Scientific is recalling Emerge Monorail PTCA Dilatation Catheters because they may lack a required hydrophilic coating. The recall covers 14,145 devices distributed nationwide and in Canada.

    Product
    Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2020·2019-12-04

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk

    Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.

    Product
    UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2020·2019-12-04

    V-Twin In Vitro Diagnostic Instruments Recalled for Sample Mismatch Risk

    Vital Scientific N.V. is recalling 732 V-Twin instruments in New York due to a risk of aspirating samples from the wrong container, which could lead to incorrect patient reports.

    Product
    V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0529-2020·2019-12-04

    Zimmer Biomet Recalls Guide Wires Due to Bacterial Endotoxin and Debris

    Zimmer Biomet is recalling specific Aim/Art Guide Wires because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V864000·2019-12-04

    Ford Recalls 2017-2019 Super Duty Trucks for Tailgate Latch Defect

    Ford is recalling 2017-2019 Super Duty trucks because water intrusion may cause the tailgate to open unexpectedly, creating a road hazard.

    Product
    FORD — FORD F-250 SD, F-350 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V861000·2019-12-04

    Fleetwood and Holiday Rambler Motorhomes Recalled for Fire Risk

    REV is recalling 2020 Fleetwood and Holiday Rambler motorhomes because an improperly secured wire harness may cause a fire.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER DISCOVERY, NAVIGATOR, ENDEAVOR, DISCOVERY LXE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2020·2019-12-04

    Zimmer Biomet Recalls Hennessy Left Constrained Glenoid Shoulder Implants

    Zimmer Biomet is recalling Hennessy Left Constrained Glenoid Humeral Shoulder Implants due to elevated bacterial endotoxin and residual debris caused by a cleaning issue.

    Product
    HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664030 Product Usage: Constrained Shoulder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2020·2019-12-04

    Kroger Mushroom Stir Fry Blend Recalled for Listeria Risk

    Renaissance Food Group is recalling 1,839 units of Kroger Mushroom Stir Fry Blend in Washington and Oregon due to potential Listeria monocytogenes contamination.

    Product
    Kroger Mushroom Stir Fry Blend 10 oz. UPC 82676618482
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0195-2020·2019-12-04

    Kroger Stir Fry Blend Recalled for Potential Listeria Contamination

    Renaissance Food Group is recalling 486 units of Kroger Stir Fry Blend due to potential Listeria monocytogenes contamination. The product was distributed in Washington and Oregon.

    Product
    Kroger Stir Fry Blend 16 oz. UPC 82676618487
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0520-2020·2019-12-04

    Zimmer Biomet Recalls Shoulder Baseplates Due to Cleaning Issues

    Zimmer Biomet is recalling COMP RVRS Shoulder Baseplates because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM555160 PM555209 PM555322 PM555406 PM555415 UDI: (01)00880304475342(17)211128(10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2020·2019-12-04

    Zimmer Biomet Recalls Compress Mini Compress Devices Due to Cleaning Issues

    Zimmer Biomet is recalling Compress Mini Compress devices because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 17857
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2020·2019-12-04

    Zimmer Biomet Recalls Custom Shoulder Implants Due to Cleaning Issues

    Zimmer Biomet is recalling specific custom shoulder replacement implants because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2020·2019-12-04

    Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination

    Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products due to a cleaning issue.

    Product
    Comprehensive RS Cleat CAP, Item No. 110300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2020·2019-12-04

    Zimmer Biomet Recalls Total Elbow Replacement Devices Due to Cleaning Issues

    Zimmer Biomet is recalling specific total elbow replacement devices because elevated levels of bacterial endotoxin and residual debris remain on them due to a cleaning issue.

    Product
    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 11475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2020·2019-12-04

    Becton Dickinson Recalls Site~Rite 8 Ultrasound Systems Due to Battery Indicator Defect

    Becton Dickinson is recalling 2,215 Site~Rite 8 Ultrasound Systems because the battery indicator may falsely show charge, causing abrupt shutdowns without warning.

    Product
    Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite¿ 8 System, Catalog No.9770500R Site~Rite 8 Ultrasound System, Catalog No.9770501 Refurbished Site~Rite¿ 8 Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide

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