The Recall Desk

Archive

December 2020 recalls

500 recalls were announced in December 2020.

What the numbers show

Critical
15
Severe
129
High
252
Moderate
97
Low
7

Of the 500 recalls this month scored against our rubric, 3% are Critical, 26% are Severe.

401–500 of 500

  • HighFDA (Devices)·Z-0532-2021·2020-12-09

    Canon Flat Panel Monitor Recall Due to Cable Breakage Risk

    Canon Medical System is recalling 14 CAS-930A Flat Panel Monitors because the cable may break during procedures, potentially causing delays or vessel damage.

    Product
    CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography conf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2021·2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage

    CME America is recalling T-Syringe Pumps because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2021·2020-12-09

    Verathon BladderScan Prime Plus Probe Recall for Handle Cracking Risk

    Verathon is recalling 398 BladderScan Prime Plus Probes because a change in handle material and process may cause the handle to crack.

    Product
    BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0140-2021·2020-12-09

    Minute Maid Strawberry Lemonade Recalled for Metal Fragment

    The Coca-Cola Company is recalling Minute Maid Strawberry Lemonade after a consumer reported a long piece of metal in the product.

    Product
    Minute Maid STRAWBERRY LEMONADE FLAVORED WITH OTHER NATURAL FLAVORS 59 FL OZ (1.8 QT) 1.75 L PRODUCED FOR THE COCA-COLA COMPANY ATLANTA, GA Unit UPC 0 25000 01970 8 Case UPC 000-25000-04812-8
    Category
    Food
    Distribution
    9 states
  • HighCPSC·21049·2020-12-09

    GrillBlazer Recalls Propane Torch Guns Due to Fire Hazard

    GrillBlazer is recalling Su-VGun and GrillGun propane torch guns because propane gas can leak, posing a fire hazard. No injuries have been reported.

    Product
    Su-VGun and GrillGun propane torch guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2021·2020-12-09

    Medtronic MiniMed 630G Insulin Pump Recalled for Battery Connection Defect

    Medtronic is recalling 206 MiniMed 630G insulin pumps due to a missing solder battery connection that could interrupt power.

    Product
    MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21050·2020-12-09

    Goal Zero Recalls Yeti 25A Fast Charge Power Supplies Due to Fire Hazard

    Goal Zero is recalling approximately 4,500 Yeti 25A Fast Charge power supplies because loose connections can overheat and cause a fire. No injuries have been reported.

    Product
    Yeti 25A Fast Charge Power Supplies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasou
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2021·2020-12-09

    CME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks

    CME America is recalling 4,182 Neofeed syringe pumps because motor wear may cause under-infusion without alarms and cracks may allow cleaning fluids to damage hardware.

    Product
    CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2021·2020-12-09

    Olympus Ultrasound Endoscope Recall for Infection Risk Reduction

    Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.

    Product
    Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E090000·2020-12-09

    Ford F-250 and F-350 pickup trucks recalled for potential steering lock-up

    Icon Vehicle Dynamics is recalling Ford F-250 and F-350 pickup trucks sold with its centerline stabilizer kit. The foam ring in the shock assembly may block piston ports, causing steering to lock up and increasing crash risk.

    Product
    FORD — FORD F-350 SD, F-250 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0207-2021·2020-12-09

    Homestead Creamery Recalls 1,344 Bottles of 10% Real Juice Lemonade

    Homestead Creamery is recalling 1,344 bottles of 10% Real Juice Lemonade due to possible contamination with chlorine sanitizer.

    Product
    Lemonade 1/2 gallon glass bottle. UPC:7525200265. "10% Real Juice Lemonade"
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0524-2021·2020-12-09

    ROi CPS Recalls Labor and Delivery Kits Due to Labeling Error

    ROi CPS LLC is recalling 220 labor and delivery kits because of an incorrect expiration date on the label.

    Product
    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2021·2020-12-09

    ICU Medical Recalls IV Administration Sets with Incorrect Filter Assemblies

    ICU Medical is recalling 1,100 units of smallbore IV administration sets due to incorrect filter assemblies. The products were distributed nationwide.

    Product
    REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0114-2021·2020-12-09

    Harvard Drug Group Recalls Aripiprazole Tablets for Dissolution Failure

    The Harvard Drug Group is recalling 841 cartons of Aripiprazole Tablets, 15 mg, because the product failed to meet dissolution specifications.

    Product
    Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2021·2020-12-09

    Golden State Medical Supply Recalls Aripiprazole Tablets for Dissolution Concerns

    Golden State Medical Supply is recalling Aripiprazole 15 mg tablets due to potential out-of-specification dissolution limits.

    Product
    ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0178-2021·2020-12-09

    JFC International Recalls Yagumo Amanatto Gift Boxes Due to Mold

    JFC International is recalling Yagumo Amanatto Gift Boxes because the imported sugar-coated sweet beans contain mold or may develop mold before the best before date.

    Product
    YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 03089 39050 4 Imported by JFC International Inc. Los Angeles, CA 90040
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0509-2021·2020-12-09

    B. Braun Introcan Safety IV Catheters Recalled for Missing 510(k) Clearance

    Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.

    Product
    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0508-2021·2020-12-09

    BD Ultra-Fine Pen Needles Recalled for Incorrect US Labeling

    Becton Dickinson is recalling 2.8 million BD Ultra-Fine Pen Needles because US cartons are missing specific compatibility information.

    Product
    BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2021·2020-12-09

    Capnostream 35 Portable Respiratory Monitor Recalled for False Temperature Display

    Covidien LLC is recalling 3,217 Capnostream 35 Portable Respiratory Monitors because they may display a false 'Temperature Exceeds Limits' message and shut down without an alarm.

    Product
    Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0142-2021·2020-12-09

    Sunnyside Farms Recalls Mislabeled Dole Savory Spinach Dijon Salad

    Sunnyside Farms is recalling Dole Savory Spinach Dijon salad because the top label incorrectly identifies the product as Candied Walnut Salad.

    Product
    Dole Brands, Savory Spinach Dijon, 4.9 oz,
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0522-2021·2020-12-09

    Chromsystems Recalls MassChrom Cortisol Saliva Control Level I Vials

    Chromsystems is recalling 880 vials of MassChrom Cortisol, Cortisone Saliva Control Level I because the control lots may not meet stability criteria, potentially causing increased patient results.

    Product
    MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0113-2021·2020-12-09

    CVS Healing Ointment Recalled for Low Weight Fill Tubes

    US Pharmaceuticals is recalling CVS Health Hydrating Healing Ointment due to low weight fill tubes identified in one lot.

    Product
    CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0519-2021·2020-12-09

    Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks

    Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.

    Product
    MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0143-2021·2020-12-09

    Bellefontaine Peanut Butter & Brownies Frozen Dessert Recalled for Labeling Error

    Bliss Texas is recalling 1,536 pints of Bellefontaine Peanut Butter & Brownies Dairy Free Frozen Dessert because peanut is missing from the ingredient statement.

    Product
    BELLEFONTAINE PEANUT BUTTER & BROWNIES DAIRY FREE FROZEN DESSERT 1 PINT (473 ML) packaged in paper cup
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0521-2021·2020-12-09

    Chromsystems Saliva Calibrator Set Recalled for Stability Issues

    Chromsystems is recalling 6PLUS1 Multilevel Saliva Calibrator Sets because they may not meet stability criteria, potentially causing increased cortisone results in patient samples.

    Product
    6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2021·2020-12-09

    Chromsystems Recalls MassChrom Cortisol and Cortisone Saliva Control Level II Kits

    Chromsystems is recalling MassChrom Cortisol, Cortisone Saliva Control Level II kits because control lots may not meet stability criteria, potentially causing increased results for patient cortisone samples.

    Product
    MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0119-2021·2020-12-09

    Teligent Pharma Recalls Clobetasol Propionate Ointment Due to Potency Issues

    Teligent Pharma is recalling Clobetasol Propionate Ointment 0.05% because some tubes have superpotent or subpotent assay results.

    Product
    Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0512-2021·2020-12-09

    Talladium Luminesse ML PMMA Milling Blank Recall for Incorrect Label

    Talladium Inc is recalling 10 units of Luminesse ML PMMA milling blanks due to incorrect labels that may cause compatibility issues with milling machines.

    Product
    Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0115-2021·2020-12-09

    InvaTech Recalls Levocetirizine Dihydrochloride Tablets Due to Stability Failure

    InvaTech Pharma Solutions is recalling specific lots of Levocetirizine Dihydrochloride Tablets 5 mg because one lot failed stability testing.

    Product
    Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V759000·2020-12-08

    Nissan Recalls 2020 Titan Trucks Due to Engine Wiring Fire Risk

    Nissan is recalling 2020 Titan and Titan XD trucks because an exposed wire in the engine harness could cause an electrical short, leading to engine stall or fire.

    Product
    NISSAN — NISSAN TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V758000·2020-12-08

    McNeilus Recalls 2020 Bridgemaster V Mixers Due to Missing Axle Information

    McNeilus is recalling 2020 Bridgemaster V Mixer trucks because the required pusher axle operating position is missing from the information plate, increasing crash risk.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER V MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V756000·2020-12-08

    2019 Mercedes-Benz Sprinter Vehicles Recalled for Inaccurate Operator's Manual

    Daimler Vans USA is recalling 2019 Mercedes-Benz Sprinter vehicles because the provided operator's manual may contain inaccurate or incomplete safety information.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 4500, SPRINTER 3500, SPRINTER 1500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-12082020-01·2020-12-08

    USDA Issues Public Health Alert for Raw Goat Meat Products

    USDA FSIS issued a public health alert for raw goat meat products produced without federal inspection. No confirmed illnesses have been reported.

    Product
    Texas Livestock & Halal Meat Processors — FSIS Issues Public Health Alert for Raw, Fresh Goat Meat Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·20V757000·2020-12-08

    Grand Design Recalls 2020 Transcend Trailers Due to Gas Leak Risk

    Grand Design is recalling 2020 Transcend recreational trailers because a gas leak at the cook stove joint may increase the risk of fire.

    Product
    GRAND DESIGN — GRAND DESIGN TRANSCEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V755000·2020-12-07

    Infiniti Recalls M56, Q70, and Hybrid Models for Driveshaft Defect

    Nissan is recalling specific Infiniti models because a broken driveshaft can cause loss of propulsion or disable the parking brake, increasing crash risk.

    Product
    INFINITI — INFINITI M56, Q70, M35 HYBRID, Q70 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V754000·2020-12-07

    2021 East to West Recreational Trailers: Stowed Grill Fire Hazard

    Forest River is recalling 2021 East to West recreational trailers (approximately 115 units). The grill can be stowed with the propane hose attached and burners on, which can increase fire risk.

    Product
    EAST TO WEST — EAST TO WEST DELLA TERRA, SILVER LAKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V752000·2020-12-04

    E-One Recalls Emergency Vehicles Due to Display Lockup Risk

    E-One is recalling specific 2019-2021 emergency vehicles because LCD displays may lock up, potentially delaying emergency efforts.

    Product
    E-ONE — E-ONE QUEST II, TYPHOON N, CYCLONE II, COMMERCIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V753000·2020-12-04

    Mercedes-Benz A 220 Recalled for Missing Tire Pressure Labels

    Mercedes-Benz is recalling 2019 A 220 vehicles because missing tire pressure labels may lead to incorrect inflation and increased crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ A 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·028-2020·2020-12-04

    Continental Glatt Kosher Meats Recalls Uninspected Meat and Poultry Products

    Continental Glatt Kosher Meats Corp. is recalling approximately 61,504 pounds of ready-to-eat meat and poultry products produced without federal inspection in New York.

    Product
    Continental Glatt Kosher Meats Corp. Recalls Ready-To-Eat Meat and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighCPSC·21711·2020-12-03

    Honda Recalls Pioneer 700 and 1000 Vehicles Due to Steering Control Issues

    American Honda is recalling approximately 118,600 Pioneer 700 and 1000 vehicles because the electric power steering system may lose control, posing crash and injury hazards.

    Product
    Honda Pioneer 700 & 1000 Recreational Off-Highway Vehicles (ROVs) with Electric Power Steering (EPS)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V751000·2020-12-03

    Land Rover Recalls 2020 Models for Speedometer Display Software Error

    Land Rover is recalling 2020 Discovery Sport and Range Rover Evoque vehicles because a software error may cause the speedometer to randomly switch units, potentially distracting drivers.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0131-2021·2020-12-02

    Whole Foods Recalls Rotisserie Chicken Meals for Undeclared Egg

    Whole Foods Market is recalling Rotisserie Chicken Meals with Mac & Cheese and Broccoli due to a potential undeclared egg allergen. The recall affects specific product codes sold in the Mid-Atlantic region.

    Product
    Rotisserie Chicken Meals with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 261596 261580, 261590, 261601, 261608, or 261616
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0138-2021·2020-12-02

    Fresh Express Kit Caesar Supreme Recalled for E. coli O26 Contamination

    Fresh Express is recalling Kit Caesar Supreme salad kits due to potential contamination with Escherichia coli STEC O26.

    Product
    FRESH EXPRESS KIT CAESAR SUPREME, Romaine Lettuce, Creamy Caesar Dressing, Italian Artisan Cheeses, Savory Garlic Croutons, Total Net WT. 10.5oz (298g)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0130-2021·2020-12-02

    Whole Foods Market Recalls Macaroni and Cheese for Undeclared Egg

    Whole Foods Market is recalling specific macaroni and cheese products due to a potential undeclared egg allergen. Consumers in five states and D.C. should check their products.

    Product
    Macaroni & Cheese, chef s case; Macaroni & Cheese, packaged in clear plastic container; Macaroni & Cheese, online and catering product code begins with 286501, 263608, 114449, or 109866
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0135-2021·2020-12-02

    Whole Foods Recalls BBQ Turkey Meatballs for Undeclared Egg

    Whole Foods Market is recalling BBQ Turkey Meatballs Chef Plates due to a potential undeclared egg allergen. The product was distributed in Maryland, New Jersey, Pennsylvania, Virginia, and Washington, D.C.

    Product
    BBQ Turkey Meatballs Chef Plate with Mac & Cheese and Green Beans, packaged in clear plastic container with printed label product code begins with 241464
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0132-2021·2020-12-02

    Whole Foods Recalls Fried Chicken Meals for Potential Undeclared Egg

    Whole Foods Market is recalling Fried Chicken Meals with Mac & Cheese in five states and D.C. due to a potential undeclared egg allergen.

    Product
    Fried Chicken Meal with Mac & Cheese, packaged in clear plastic container with printed label product code begins with 247257; Fried Chicken Meal with Mac & Cheese, packaged on hot bar product code begins with 237444
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0133-2021·2020-12-02

    Whole Foods Chicken Rustico Romano Chef Plate Recalled for Undeclared Egg

    Whole Foods Market is recalling Chicken Rustico Romano Chef Plates due to potential undeclared egg. The product was distributed in five states and Washington, D.C.

    Product
    Chicken Rustico Romano Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 241442
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·20V750000·2020-12-02

    Kia Recalls 294,756 Vehicles for Engine Compartment Fire Risk

    Kia is recalling 294,756 vehicles from 2011-2015 due to a risk of engine compartment fire while driving. Dealers will inspect for leaks and update software.

    Product
    KIA — KIA FORTE KOUP, SOUL, FORTE, SORENTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0484-2021·2020-12-02

    Hill-Rom Recalls Life2000 Ventilation Systems Due to Fire Risk

    Hill-Rom is recalling 67 Life2000 Ventilation Systems because they pose a risk of fire under certain conditions. The devices are used in home and institutional settings.

    Product
    Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0103-2021·2020-12-02

    Paroex Oral Rinse Recalled for Burkholderia lata Contamination

    Sunstar Americas is recalling Paroex Oral Rinse due to microbial contamination with Burkholderia lata. The recall covers specific lots distributed nationwide.

    Product
    Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0137-2021·2020-12-02

    GT's Living Foods Recalls Synergy Raw Kombucha Multi-Green

    GT's Living Foods is recalling Synergy raw kombucha Multi-Green due to high levels of microcystins found by FDA sampling.

    Product
    Synergy raw kombucha - Multi-Green; 16 fl. oz. (473 mL) UPC 7 22430 14016 2 GT's Living Foods LLC Beverly Hills, CA
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0102-2021·2020-12-02

    SYP Health Hand Sanitizer Recalled for CGMP Deviations and Methanol Risk

    AA Products Inc. is recalling SYP Health Hand Sanitizer Alcohol Gel due to CGMP deviations and a history of subpotent ethanol and methanol contamination at the manufacturing facility.

    Product
    SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0481-2021·2020-12-02

    ViewRay MRIdian System Recalled for Potential Burn Injury Risk

    ViewRay is recalling three MRIdian systems because receive coil components may reach elevated temperatures, posing a potential risk of burn injury to patients or users.

    Product
    ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0134-2021·2020-12-02

    Whole Foods Chicken Breast Chef Plate Recalled for Undeclared Egg

    Whole Foods Market is recalling Chicken Breast Chef Plate with Mac & Cheese and Broccoli due to potential undeclared egg.

    Product
    Chicken Breast Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 299430
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·20V749000·2020-12-02

    Audi 2021 A6, Q7, RS6, and RS7 Crash Sensor Electrical Defect

    Volkswagen Group of America (Audi) is recalling 2021 Audi A6, Q7, RS6, and RS7 vehicles. An electrical connector can detach from door crash sensors, potentially delaying restraint system activation during side-impact crashes.

    Product
    AUDI — AUDI RS 6 AVANT, RS 7, A6, Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2021·2020-12-02

    FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk

    Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.

    Product
    Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2021·2020-12-02

    Bayer Recalls MEDRAD Stellant FLEX Syringe Kits Due to Cracks

    Bayer Medical Care is recalling specific lots of MEDRAD Stellant FLEX 150 mL syringe kits because they may have holes or cracks that allow fluid to leak.

    Product
    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0109-2021·2020-12-02

    Eywa Pharma Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

    Eywa Pharma Inc. is recalling 500 mg Levetiracetam tablets because a 1000 mg tablet was found in a 500 mg bottle.

    Product
    Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2021·2020-12-02

    RayStation software recall for potential incorrect treatment plan references

    RaySearch Laboratories is recalling RayStation software because missing data may cause treatment plans to reference incorrect regions or points of interest.

    Product
    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation propose
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2021·2020-12-02

    FDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk

    Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen units because granules may be expelled all at once, posing a risk of tissue injury.

    Product
    Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·21040·2020-12-02

    Huffy Recalls Torex Ride-on Toy UTVs Due to Injury Hazard

    Huffy is recalling Torex 24V ride-on toy UTVs sold at Walmart because the toys can unexpectedly move when the battery is connected, posing an injury hazard.

    Product
    Huffy Torex 24V ride-on toy UTVs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2021·2020-12-02

    Intuitive Surgical Recalls ION Fully Articulating Catheters Due to Tip Ring Risk

    Intuitive Surgical is recalling 454 ION Fully Articulating Catheters because the distal tip ring may become dislodged during use.

    Product
    Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2021·2020-12-02

    Conformis Recalls iTotal Hip Replacement System Due to Incorrect Components

    Conformis, Inc. is recalling two iTotal Hip Replacement Systems because incorrect hip components were provided in the kits.

    Product
    iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0482-2021·2020-12-02

    ViewRay MRIdian Linac System Recalled for Potential Burn Injury Risk

    Viewray, Inc. is recalling 35 ViewRay MRIdian Linac Systems because receive coil components may reach elevated temperatures, posing a risk of burn injury to patients or users.

    Product
    ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2021·2020-12-02

    Natural Grocers Organic Elderberries Recalled for Salmonella Contamination Risk

    Natural Grocers is recalling 4 oz. bags of Whole Organic Elderberries due to potential Salmonella contamination. Consumers should check their pantry for the specific UPC and lot codes.

    Product
    Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), plastic bag, UPC 0-0082-00304-3
    Category
    Food
    Distribution
    20 states
  • HighFDA (Food)·F-0125-2021·2020-12-02

    Roshni Foods Green Raisins Recalled for Undeclared Sulfites

    Singh Trading Inc. DBA Roshni Foods is recalling Green Raisins due to undeclared sulfites. The product was distributed to retail stores in NC, MD, VA, and PA.

    Product
    Green Raisins 200 grams (7 oz.) Packaged in plastic bags. Bar Code:992203621
    Category
    Food
    Distribution
    4 states
  • HighCPSC·21039·2020-12-02

    ADCO Recalls Sure Scents Candles Due to Fire and Burn Hazards

    ADCO is recalling Sure Scents 2-1 Peaceful Stream/Moonlit Waves candles sold at Dollar Tree because high flames can ignite wax or break glass, posing fire and burn risks.

    Product
    Sure Scents 2-1 Peaceful Stream/Moonlit Waves Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0136-2021·2020-12-02

    Whole Foods Recalls Roasted Turkey Chef Plate for Undeclared Egg

    Whole Foods Market is recalling Roasted Turkey Chef Plates with Mac & Cheese and Broccoli due to a potential undeclared egg allergen.

    Product
    Roasted Turkey Chef Plate with Mac & Cheese and Broccoli, packaged in clear plastic container with printed label product code begins with 242019
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0497-2021·2020-12-02

    Flexicare ProVu Video Stylet Recalled for Potential Airway Occlusion

    Flexicare Medical Ltd. is recalling ProVu Single Use Video Stylets with ET Tubes because over-inflated cuffs may block the airway, making it difficult to ventilate patients.

    Product
    ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2021·2020-12-02

    Geistlich Bio-Oss Pen Recalled Due to Granule Expulsion Risk

    Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen 1-2mm 0.5g units because granules may be expelled all at once, posing a risk of tissue injury.

    Product
    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2021·2020-12-02

    Coloplast Titan Pump Recall for Potential Device Fracture

    Coloplast is recalling 8,962 Titan Pump units due to a potential increased occurrence of pump fracture over the device's lifetime.

    Product
    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2021·2020-12-02

    Mevion Proton Radiation Treatment System Recalled for Screen Display Failure

    Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.

    Product
    MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0128-2021·2020-12-02

    High Quality Organics Recalls Organic Thyme Leaves for Salmonella Risk

    High Quality Organics is recalling specific lots of Organic Thyme Leaves due to potential Salmonella contamination. The product was distributed to several U.S. states.

    Product
    HQO High Quality Organics Organic Thyme Leaves, Whole Net Weight 30 lbs., 500 lbs. High Quality Organics 1201 Moya Boulevard Reno, Nevada 89506 Certified Organic by QAI
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0476-2021·2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Service Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate and verify the devices.

    Product
    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0104-2021·2020-12-02

    Jubilant Cadista Recalls Clomipramine Hydrochloride Capsules Due to Specification Failure

    Jubilant Cadista Pharmaceuticals is recalling 4,416 bottles of clomipramine hydrochloride capsules because they failed tablet/capsule specifications.

    Product
    clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0495-2021·2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects

    Medtronic is recalling 15 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0110-2021·2020-12-02

    Teligent Recalls Subpotent Triamcinolone Acetonide Lotion

    Teligent Pharma is recalling one lot of Triamcinolone Acetonide Lotion because it does not meet assay results.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0107-2021·2020-12-02

    Fusion Health Immune Boost Recalled for Marketing Without FDA Approval

    Fusion Health and Vitality LLC is recalling 5,000 bottles of Immune Boost because the product was marketed with drug claims without an approved NDA or ANDA.

    Product
    Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2021·2020-12-02

    Luminex Recalls Verigene Processor SP Due to Unapproved Test Fixtures

    Luminex is recalling 2,838 Verigene Processor SP units because field service engineers used unapproved test fixtures to calibrate the devices.

    Product
    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2021·2020-12-02

    Medtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects

    Medtronic is recalling 3 units of Cardioblate CryoFlex Surgical Ablation Probes because of a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at it
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0479-2021·2020-12-02

    Encore Medical Recalls EMPOWR Partial Knee Peg Drill Guide

    Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill Guide because the drill shaft may bind during use, potentially delaying surgery.

    Product
    EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0480-2021·2020-12-02

    Encore Medical Recalls EMPOWR Partial Knee Peg Drill Due to Binding

    Encore Medical is recalling 28 units of the EMPOWR Partial Knee Peg Drill because the shaft may bind within the guide, potentially delaying surgery.

    Product
    EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0493-2021·2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects

    Medtronic is recalling 37 units of the Cardioblate CryoFlex Surgical Ablation Probe due to potential defects in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring tem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0486-2021·2020-12-02

    Advanced Bionics Recalls Mislabelled PowerCel 230 Cochlear Implant Batteries

    Advanced Bionics is recalling 53 PowerCel 230 batteries for cochlear implants because they may be mislabeled with incorrect battery life information.

    Product
    AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0108-2021·2020-12-02

    Heritage Pharmaceuticals Recalls Felodipine Extended Release Tablets Due to Impurities

    Heritage Pharmaceuticals is recalling specific bottles of Felodipine Extended Release Tablets because routine testing found out-of-specification impurities.

    Product
    Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0494-2021·2020-12-02

    Medtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects

    Medtronic is recalling 57 units of the Cardioblate CryoFlex Surgical Ablation Probe due to a potential defect in the sterile barrier pouch seals.

    Product
    Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0129-2021·2020-12-02

    Sysco Arrezzio Diced Tomatoes Recalled for Foreign Plastic Material

    The Neil Jones Food Company is recalling Sysco Arrezzio diced tomatoes due to the presence of hard black plastic.

    Product
    Sysco Arrezzio 3/8" Petite Diced Tomatoes in Tomato Puree, #7807458, each metal can has the net weight of 6.38 lbs. (2.89 kg). UPC 7 34730 21799 4. The label is read in parts: "***Arrezzio Petite Diced Tomatoes in Tomato Puree *** INGREDIENTS: Vined-Ripened Tomatoes, Salt, Ci
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-0487-2021·2020-12-02

    Advanced Bionics Recalls 28 Mislabelled Cochlear Implant Batteries

    Advanced Bionics is recalling 28 AB PowerCel 170 batteries due to mislabeling that may indicate incorrect battery life.

    Product
    AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V744000·2020-12-01

    Vac-Tron Recalls Excavator Trailers Lacking Rear Impact Guards

    Vac-Tron is recalling specific excavator trailers because they lack required rear impact guards, increasing the risk of injury if struck from behind.

    Product
    VAC-TRON — VAC-TRON LPSGT, LP 873 XDT, LP 873 SGT, LPXDT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V747000·2020-12-01

    Nissan Recalls 2002-2006 Sentra Vehicles for Takata Air Bag Defect

    Nissan is recalling 2002-2006 Sentra vehicles because passenger air bag inflators may explode in a crash, posing a risk of serious injury or death.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V748000·2020-12-01

    Hyundai Recalls Kona Electric and Nexo for Brake Software Defect

    Hyundai is recalling 2019-2021 Kona Electric and 2019-2020 Nexo vehicles because a software issue may reduce braking performance, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI KONA ELECTRIC, NEXO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V745000·2020-12-01

    Halcore Recalls 2020 Horton Emergency Vehicles Due to Display Failure

    Halcore is recalling 2020 Horton Type I and III emergency vehicles because a display processor may stop working, potentially delaying emergency services.

    Product
    HORTON — HORTON TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide

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