The Recall Desk

Archive

December 2022 recalls

608 recalls were announced in December 2022.

What the numbers show

Critical
4
Severe
95
High
343
Moderate
165
Low
1

Of the 608 recalls this month scored against our rubric, 1% are Critical, 16% are Severe.

Which agencies issued them

501–600 of 608

  • HighFDA (Devices)·Z-0357-2023·2022-12-14

    Dover Urethral Catheter Drainage System Recall for Potential Port Blockage

    Cardinal Health is recalling Dover closed urethral catheter trays because the drainage bag port may become occluded, preventing urine from draining properly and increasing the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2023·2022-12-14

    Spinal Implant Screws Recalled Due to Potential Weld Failure

    LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2023·2022-12-14

    HF Resection Electrodes Recalled for Incompatible Packaged Cable

    Olympus Corporation is recalling HF Resection Electrodes because an incompatible cable may be included in packaging. The cable cannot connect to the electrosurgical generator, potentially delaying or canceling surgery.

    Product
    HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2023·2022-12-14

    Bipolar forceps recalled for incomplete instructions for use

    Carefusion V. Mueller bipolar forceps are recalled because their instructions are missing information on power supply interface and cleaning procedures. Users should obtain the complete manufacturer instructions.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5014
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2023·2022-12-14

    Carefusion Bipolar Surgical Forceps Recalled for Missing Instructions

    Carefusion 2200 Inc. is recalling 41 units of Hardy Bayonet Irrigating Bipolar Forceps due to incomplete instructions for use. The supplied instructions lack content about device power supply interface and maintenance procedures.

    Product
    Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-1335
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Missing Instruction Manual Content

    CareFusion bipolar forceps recalled due to missing instructions on power supply interface and cleaning/maintenance procedures. Corrected documentation is now available.

    Product
    CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM TIP OVERALL LENGTH 6" (150MM) , REF F-5128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2023·2022-12-14

    Bipolar Forceps Device Incomplete Instructions for Use Recalled

    CareFusion bipolar forceps (REF F-5061) recalled due to incomplete Instructions for Use missing device power supply interface and cleaning instruction content.

    Product
    CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0425-2023·2022-12-14

    FAST Sample Preparation System Labeling Corrected for Regulatory Scope

    Qvella is correcting documentation for the FAST System, a blood culture sample preparation device, because it exceeded its original regulatory scope. The company is updating manuals and promotional materials to clarify approved applications.

    Product
    The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0379-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Instructions for Use

    Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.

    Product
    Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2023·2022-12-14

    Carefusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.

    Product
    Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion bipolar forceps are recalled due to incomplete manufacturer instructions for use. Missing content covers power supply interface and device maintenance and cleaning procedures.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2023·2022-12-14

    Bipolar Forceps Recall: Missing Instructions for Power Supply and Maintenance

    CareFusion bipolar forceps are being recalled due to missing Instructions for Use content about power supply interface, cleaning, and maintenance. Users should obtain the complete manufacturer instructions immediately.

    Product
    CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0414-2023·2022-12-14

    CareFusion Bipolar Surgical Forceps Recalled for Incomplete Instructions

    CareFusion bipolar surgical forceps are being recalled because their instruction manual is missing critical information about power supply interface and cleaning procedures. BD is providing corrected instructions to healthcare facilities.

    Product
    CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED STRAIGHT FINE, 0.5MM TIP OVERALL LENGTH 8-3/4" (225MM), REF F-5302
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2023·2022-12-14

    CareFusion Bipolar Surgical Forceps Recalled by FDA Class II Voluntary Action

    CareFusion initiated a voluntary recall of bipolar forceps surgical instruments. The recall affects 4 units distributed nationwide and internationally.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TIP OVERALL LENGTH 9-1/2" (240MM) , REF F-5008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled: Incomplete Instructions for Power Supply

    CareFusion is recalling bipolar forceps units due to incomplete instructions for power supply interface and device maintenance. The recall affects devices distributed worldwide.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.

    Product
    CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2023·2022-12-14

    Bipolar forceps recalled for incomplete instructions for use

    Carefusion recalled certain bipolar forceps due to incomplete Instructions For Use. The IFU was missing content about the device's power supply interface and cleaning and maintenance procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGTH 7-1/2" (190MM), REF F-1111
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2023·2022-12-14

    IgA and IgM Immunoturbidimetric Assay Testing Order Carryover Avoidance Update

    Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).

    Product
    IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2023·2022-12-14

    Bipolar Forceps Recall Due to Incomplete Instructions for Use

    Carefusion is recalling 259 surgical bipolar forceps units because the Instructions for Use are missing critical information about power supply interface and maintenance procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0417-2023·2022-12-14

    CareFusion Bipolar Surgical Forceps Recalled for Incomplete Operating Instructions

    CareFusion bipolar surgical forceps recalled for incomplete Instructions for Use. Documentation is missing information on power supply interface and cleaning procedures.

    Product
    CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH 6" (150MM), REF F-52000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0386-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

    Carefusion bipolar surgical forceps recalled nationwide due to incomplete Instructions for Use. The distributed IFU is missing guidance on power supply interface and cleaning and maintenance procedures.

    Product
    Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0411-2023·2022-12-14

    Bipolar Forceps Recall: Missing Power Supply and Cleaning Instructions

    Carefusion is recalling bipolar forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning procedures.

    Product
    CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 0.5MM TIP, ANGLED-UP FINE OVERALL LENGTH 8-3/4" (225MM), REF F-5127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2023·2022-12-14

    Port Access Kits incorrectly labeled as IV Start Kits

    Medical Action Industries is recalling Port Access Kits that are incorrectly labeled as IV Start Kits on the individual kit label. The case label is correct; mislabeling could cause confusion about the product's identity.

    Product
    Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, REF #78019 (on kit label), sterile. Kit components are the Port Access Kit.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0384-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Power Supply and Maintenance Instructions

    Carefusion recalls bipolar forceps due to incomplete Instructions for Use missing power supply interface and maintenance guidance. No injuries reported.

    Product
    Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0186-2023·2022-12-14

    Betty Buzz Sparkling Grapefruit Recalled for Off-Odor

    Betty Buzz LLC is recalling Betty Buzz Sparkling Grapefruit non-alcoholic beverage nationwide due to detected off-odor in the product. The recall affects 939 cases containing 22,536 bottles.

    Product
    Betty Buzz Sparkling Grapefruit - Non-alcoholic Beverage & Mixer Container Description: 4 x 9oz Bottles in Pack 24 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2023·2022-12-14

    Surgical Bipolar Forceps Recalled for Incomplete Operating Instructions

    Carefusion is recalling bipolar surgical forceps due to incomplete Instructions for Use. The missing instructions cover power supply interface and cleaning procedures.

    Product
    Carefusion V. Mueller" CUSHING BAYONET BIPOLAR FORCEPS, 2.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-2004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0388-2023·2022-12-14

    Bipolar Irrigating Forceps Recall: Missing Power Supply and Maintenance Instructions

    Carefusion is recalling 132 units of V. Mueller bipolar irrigation forceps due to incomplete instruction manuals missing power supply interface and maintenance guidance.

    Product
    Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM), REF F-1305
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0402-2023·2022-12-14

    Medical Device Recall: Missing Instructions for Bipolar Surgical Forceps

    CareFusion bipolar forceps recalled because the provided instructions are missing critical information about power supply interface and cleaning procedures. No injuries reported.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V921000·2022-12-13

    2021 Porsche Taycan Suspension Strut Defect May Cause Loss of Vehicle Control

    A retaining ring on the 2021 Porsche Taycan's suspension strut may come loose, causing loss of vehicle control and increasing crash risk. Repairs will be provided free by Porsche dealers.

    Product
    PORSCHE — PORSCHE TAYCAN, TAYCAN 4S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V922000·2022-12-13

    2023 Jayco Solstice defrost controls may fail, increasing crash risk

    Jayco is recalling 2023 Solstice and Entegra Expanse recreational vehicles because the HVAC system's defrost and defog controls may stop working. This loss of visibility control increases the risk of crashes under certain driving conditions.

    Product
    ENTEGRA — ENTEGRA, JAYCO EXPANSE, SOLSTICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V920000·2022-12-13

    2023 Forest River Travel Trailers Recalled for Refrigerator Wiring Fire Risk

    Forest River is recalling certain 2023 Wildwood, Salem, and Stealth EVO travel trailers. The 8-gauge refrigerator wire lacks over-current protection, creating a fire risk from melted wiring.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, STEALTH EVO, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V917000·2022-12-12

    Volvo Bus 9700 Recalled for GPS Installation Defect

    Volvo Bus is recalling 2022 9700 buses because incorrectly installed GPS devices may cause accelerator sensor malfunction and loss of drive power.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V919000·2022-12-12

    Freightliner and Western Star trucks recalled for tire incompatibility

    Daimler Trucks is recalling certain Freightliner and Western Star commercial trucks with tires incompatible with their 8.25-inch rims. Incompatible tires can reduce performance and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR 122SD, 114SD, BUSINESS CLASS M2, 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23066·2022-12-12

    Art of Green Laundry Detergent Recalled for Bacterial Contamination

    AlEn USA is recalling Art of Green laundry detergent products because they may contain Pseudomonas aeruginosa bacteria, which can cause serious infection in people with weakened immune systems or external medical devices.

    Product
    Art of Green laundry detergent products
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V912000·2022-12-09

    Kawasaki Recalls Motorcycles Due to Camshaft Chain Tensioner Defect

    Kawasaki is recalling specific 2015-2023 motorcycles because a defective camshaft chain tensioner may lock, causing the engine to stall while riding.

    Product
    KAWASAKI — KAWASAKI Z H2, NINJA H2 SX, NINJA H2, NINJA 1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V911000·2022-12-09

    Braun Ambulances Recall 2014-2022 Models Due to HVAC Fire Risk

    Braun Ambulances is recalling 1,321 vehicles from 2014-2022 because a faulty relay may cause the HVAC system to overheat, increasing the risk of a fire.

    Product
    BRAUN AMBULANCES — BRAUN AMBULANCES SUPER CHIEF, LIBERTY, PATRIOT, SIGNATURE SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V905000·2022-12-08

    Hyundai Translead Recalls 2020-2021 Trailers Due to Brake Pad Retaining Clip Defect

    Hyundai Translead is recalling 2020-2021 Dry Van and Reefer Trailers because a loose brake pad retaining clip may detach, reducing brake performance or causing a flat tire.

    Product
    HYUNDAI TRANSLEAD — HYUNDAI TRANSLEAD REEFER TRAILER, DRY VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V910000·2022-12-08

    Navistar Recalls 2023 IC CE and IN RE Buses for Axle Fastener Issue

    Navistar is recalling 2023 IC CE and IN RE commercial buses because incorrectly tightened fasteners may allow the rear axle to shift, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS RE, CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V906000·2022-12-08

    2023 KIA Forte front left steering knuckle may crack

    Kia is recalling certain 2023 Forte vehicles due to a manufacturing error that may cause the front left steering knuckle to crack, resulting in loss of steering control and increased crash risk.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23064·2022-12-08

    3M Scotch TL1302 Thermal Laminators Recalled Due to Fire Hazard

    3M is recalling approximately 516,500 Scotch TL1302 Thermal Laminators because a safety feature can malfunction when the device overheats, posing a fire hazard. The company has received nine reports of the laminators catching fire, with three reports of minor property damage but no injuries.

    Product
    Scotch TL1302 Thermal Laminators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V908000·2022-12-08

    2023 McLaren Artura recalled for fuel pipe defect increasing fire risk

    McLaren is recalling 164 2023 Artura vehicles because high-pressure fuel pipe nuts may loosen, causing fuel leaks that could lead to fires. Dealers will replace the fuel pipes at no cost.

    Product
    MCLAREN — MCLAREN ARTURA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23065·2022-12-08

    Ortal Gas Fireplaces Recalled Due to Fire Hazard Risk

    Ortal USA is recalling about 400 Traditional 90 and Traditional 110 gas fireplaces due to improper installation that can cause fire hazards. The firm has received four reports of installation errors resulting in fires with property damage.

    Product
    Traditional 90 and Traditional 110 Gas Fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V909000·2022-12-08

    School buses recalled for incorrectly tightened rear axle fasteners

    Navistar is recalling certain 2023-2024 IC BUS school buses due to fasteners on the rear axle that may have been tightened incorrectly. This can allow the rear axle to shift, reducing vehicle control and increasing crash risk.

    Product
    IC BUS — IC BUS CESB, RESB, EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V907000·2022-12-08

    Subaru Ascent 2019–2022 Recall for Electrical Fire Risk

    Subaru is recalling 2019–2022 Ascent vehicles due to an improperly fastened ground bolt on the PTC heater that could melt and cause an electrical fire.

    Product
    SUBARU — SUBARU ASCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23057·2022-12-08

    Cordless Window Shades Battery Packs Recalled for Fire Hazard

    About 56,000 lithium-ion battery packs used in cordless window blinds are being recalled because they can overheat and pose a fire hazard. The firm has received reports of overheating and one fire in a commercial warehouse, though no consumer injuries have been reported.

    Product
    Cordless Window Shades Battery Packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V903000·2022-12-08

    GM recalls multiple 2020-2023 vehicles for daytime running light control defect

    General Motors is recalling multiple 2020-2023 models because daytime running lights may fail to turn off when headlights are on, creating glare and visibility hazards.

    Product
    BUICK — BUICK, CADILLAC, CHEVROLET ENVISION, CT5, CT4, ESCALADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V904000·2022-12-08

    2019-2022 RAM Pickup Trucks Recalled for Defective Tailgate Latch

    Chrysler is recalling 2019-2022 RAM 1500, 2500, and 3500 pickup trucks because the tailgate may not latch properly due to misaligned strikers. An unintended tailgate opening while driving could result in cargo loss and increased crash risk.

    Product
    RAM — RAM 3500, 2500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·23063·2022-12-08

    Life is Good Darkest Blue Fleece Sweatshirts and Shorts Recall

    The Life is Good Company is recalling approximately 750 Fall 2022 Darkest Blue fleece sweatshirts and men's shorts that fail to meet federal flammability standards for clothing textiles, posing a risk of burn injuries.

    Product
    Fall 2022 Darkest Blue Fleece Women's Sweatshirts and Men's Shorts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0182-2023·2022-12-07

    Choi Heong Yuen Bakery Almond Cakes recalled for undeclared milk allergen

    Choi Heong Yuen Bakery Almond Cakes may contain undeclared milk. Consumers with milk allergies who purchased this product should stop consuming it and contact the manufacturer.

    Product
    Choi Heong Yuen Bakery Almond Cakes in round metal container Ingredients: mung bean powder (cereal containing gluten), sugar, almond (tree nuts), vegetable oil (canola oil), peanuts; (may contain traces of walnut, egg, and milk). Packed in cases of 12 units Store in cool, dry p
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0342-2023·2022-12-07

    CMV IgM EIA Diagnostic Test Recalled for Increased False Positives

    Bio-Rad Laboratories is recalling 180 CMV IgM EIA diagnostic test kits due to unusually high rates of false positive results. The recall affects test kits distributed in 14 U.S. states.

    Product
    CMV IgM EIA, in vitro diagnostic.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0354-2023·2022-12-07

    Alcon Surgical Procedure Packs Recalled for Adhesive Defect and Skin Injuries

    Alcon is recalling Custom Pak Surgical Procedure Packs because the adhesive liner is difficult to remove and the manufacturer has observed an increase in skin injuries related to the adhesive.

    Product
    Alcon Custom Pak Surgical Procedure Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2023·2022-12-07

    Surgical Gown Recall Due to Potential Open Seal Pouches Affecting Sterility

    Owens & Minor Distribution recalls Aero Blue Performance Surgical Gowns due to potential open seal pouches that could compromise sterility and result in non-sterile products being used in surgery.

    Product
    Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0324-2023·2022-12-07

    CoViPoint COVID Test Kits Distributed Without FDA Approval or Clearance

    GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.

    Product
    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0348-2023·2022-12-07

    Medical device test system recalled for decreased reactivity and false-negative results

    Greer Laboratories recalled a hypersensitivity pneumonitis test kit (102 units, Lot 389592) after stability testing revealed decreased reactivity that could cause false-negative results. The issue was discovered in October 2021.

    Product
    GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Drugs)·D-0071-2023·2022-12-07

    Daytrana transdermal methylphenidate patches recalled for adhesive defect

    Noven Pharmaceuticals recalls 3,977 boxes of Daytrana methylphenidate transdermal patches nationwide due to defective adhesive properties in lot 91316. Affected patches may fail to adhere properly or deliver medication inconsistently.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2023·2022-12-07

    Diagnostic Kit Recalled for False Positive Bacterial Identification Results

    Accelerate Diagnostics is recalling the Accelerate PhenoTest BC kit due to improperly formulated FISH probes that produce false positive identification results for Staphylococcus aureus and Streptococcus species. Approximately 7,160 kits have been distributed across the United States and internationally.

    Product
    Accelerate PhenoTest BC kit REF 10102018
    Category
    Medical Device
    Distribution
    31 states
  • HighNHTSA·22V902000·2022-12-07

    Nova Bus Recalls LFS Models for Non-Standard Auxiliary Lighting

    Nova Bus is recalling 2009-2021 LFS and LFS Artic transit buses because non-standard color auxiliary lights may distract other drivers and increase crash risk.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0072-2023·2022-12-07

    FDA recalls prescription desmopressin acetate tablets for subpotency

    Heritage Pharmaceuticals' desmopressin acetate tablets (0.2mg) have been recalled nationwide due to subpotency. The voluntary recall affects 13,805 bottles; no illnesses have been reported.

    Product
    DESMOPRESSIN ACETATE — DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0180-2023·2022-12-07

    Amy's Kitchen Gluten Free Bean and Cheese Burritos Recalled for Plastic Contamination

    Amy's Kitchen is recalling Gluten Free Bean and Cheese Burritos (Lot 30H0922, best before 08/2024) due to potential plastic pieces in the product. Approximately 5,134 cases were distributed to 18 U.S. states.

    Product
    Amy's Kitchen Gluten Free Bean and Cheese Burrito 5.5 oz. individually wrapped plastic packages - 12 units per case UPC - 042272-00353-2 Frozen INGREDIENTS: ORGANIC PINTO BEANS, FILTERED WATER, ORGANIC BROWN RICE, ORGANIC GARBANZO BEAN FLOUR, ORGANIC TOMATO PUR¿E, WHITE CHEDDAR A
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-0347-2023·2022-12-07

    Medical laboratory reagent recalled for potential false-negative test results

    Greer Laboratories recalled a hypersensitivity pneumonitis test reagent (Lot 389591) due to decreased reactivity that could cause false-negative results. The issue affects 218 units distributed across 12 U.S. states and two countries.

    Product
    GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test system, gel diffusion kit for demonstrating precipitating antibodies.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0181-2023·2022-12-07

    Fudgeamentals Chocolate Fudge Bites recalled for undeclared tree nuts

    Fudgeamentals Chocolate Fudge Bites (8 oz) are being recalled because they contain undeclared tree nuts. Consumers with tree-nut allergies are at risk of allergic reaction.

    Product
    Fudgeamentals Chocolate Fudge Bites (8 oz); packaged in clear plastic container
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0344-2023·2022-12-07

    Mobile CT Scanner Battery Fire Risk in Units With Bypassed Monitoring

    Mobius Imaging is recalling MobiCT-32 AIRO Mobile CT Scanner units due to a reported battery fire in devices where battery monitoring systems were bypassed. The affected units' batteries must be replaced.

    Product
    MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0340-2023·2022-12-07

    Intuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure

    Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.

    Product
    INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0345-2023·2022-12-07

    Accelerate PhenoTest BC Kit Recall Due to False Positive Bacterial Identification

    Accelerate Diagnostics is recalling 200 kits of the Accelerate PhenoTest BC diagnostic test due to improperly formulated FISH probes that may produce false positive results for Staphylococcus aureus and Streptococcus bacteria.

    Product
    Accelerate PhenoTest BC kit REF 10101018
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Drugs)·D-0074-2023·2022-12-07

    Acella Recalls Sodium Sulfacetamide Cleansing Pads for Subpotency

    Acella Pharmaceuticals is recalling Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because testing found the drug out of specification for potency at shelf-life expiration. 528 cartons distributed nationwide are affected.

    Product
    Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·22V901000·2022-12-07

    Audi Recalls 2023 S3, RS3, and A3 for Missing Weight Label

    Volkswagen Group of America is recalling 2023 Audi S3, RS3, and A3 vehicles because the B-pillar safety label is missing weight capacity information.

    Product
    AUDI — AUDI S3, RS 3, A3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0353-2023·2022-12-07

    Laboratory Diagnostic Probe Recalled for Incorrect Chromosome Map Labeling

    Cytocell Ltd. recalls CytoCell BCL11B Proximal probe used in T-cell malignancy testing (lot RD22/230/10). The package insert contains an incorrect chromosome map that doesn't match the probe design.

    Product
    CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0179-2023·2022-12-07

    Coolhaus Dairy Free Frozen Dessert Recalled for Coliform Detection

    Coolhaus Dairy Free Cookie Dough Lyfe frozen dessert sandwiches recalled due to coliform detected in lab samples. Product distributed to select retailers in Texas, Maryland, Colorado, and California.

    Product
    Coolhaus Dairy Free Cookie Dough Lyfe Frozen Dessert Sandwich 3 pk units - 8.75 oz (2.9 oz./unit) UPC: 8 5000988328 5 Distributed by Coolhaus 8688 Washington Blvd. Culver City, CA 90232
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0350-2023·2022-12-07

    Medical diagnostic control kit recalled for out-of-range quality control results

    Primus Corporation recalls Trinity Biotech HbA1c Control Kits because Control Level I material produces out-of-range results that cause analyzer malfunction and testing delays, potentially delaying patient results.

    Product
    Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0326-2023·2022-12-07

    Surgical Injection Tray Recalled Due to Adhesive Liner Defect

    Busse Hospital Disposables is recalling 40 cases of Busse Spine Injection Trays containing 3M Steri-Drape Surgical Drapes distributed in Texas due to a defective adhesive liner that is difficult to remove without damaging the product.

    Product
    Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0341-2023·2022-12-07

    BCL11B Diagnostic Reagent Recalled for Chromomap Documentation Error

    Cytocell Ltd. is recalling a diagnostic reagent due to an error in the chromomap on the package insert. The nucleotide locations in the text are correct, but the chromosome map was created using incorrect coordinates.

    Product
    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0349-2023·2022-12-07

    Hemoglobin A1c Control Material Produces Incorrect Test Results

    A. MENARINI diagnostics hemoglobin A1c control materials (Lot 12161) are producing incorrect results that cause analyzer errors and prevent diagnostic testing. Facilities using this lot should discontinue use and contact the manufacturer.

    Product
    A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0325-2023·2022-12-07

    3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Liner Defect

    3M is recalling Steri-Drape Surgical Drapes because the liner on the adhesive component is difficult to remove without damaging the product, potentially rendering it unusable.

    Product
    Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0073-2023·2022-12-07

    Allergy Relief D tablets recalled for failed dissolution specifications

    Dr. Reddy's Laboratories is recalling Allergy Relief D extended-release tablets distributed nationwide by Walmart due to failed dissolution specifications. No illnesses or injuries have been reported.

    Product
    Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V899000·2022-12-06

    Kia Recalls 2020 Niro EV Vehicles for EPCU Coolant Leak Risk

    Kia is recalling 2020 Niro EV vehicles because a coolant leak in the Electric Power Control Unit may cause loss of drive power, increasing crash risk.

    Product
    KIA — KIA NIRO EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V898000·2022-12-06

    Hino Recalls 2022-2023 Trucks Due to Fuel Pickup Tube Defect

    Hino is recalling 970 specific 2022-2023 models because a fuel tube may restrict fuel flow, potentially causing engine stalls and increasing crash risk.

    Product
    HINO — HINO NJ7A, NJ7B, NV7A, NE7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V900000·2022-12-06

    KTM 1290 Super Duke R Motorcycles Recalled for Electrical Wiring Defect

    KTM is recalling 2020-2022 1290 Super Duke R motorcycles because the main wiring harness may be misrouted or missing parts, potentially causing an electrical short-circuit and engine stall.

    Product
    KTM — KTM 1290 SUPER DUKE R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V896000·2022-12-06

    Volvo Recalls 2022-2023 VNL Vehicles for Air Tank Bracket Defect

    Volvo Trucks is recalling certain 2022-2023 VNL vehicles because excessively tightened air tank bracket fasteners may break, allowing the air tank to detach and become a road hazard.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2022·2022-12-05

    Kraft Heinz Recalls Oscar Mayer Ham and Cheese Loaf Due to Cross-Contamination

    Kraft Heinz is recalling approximately 2,400 pounds of Oscar Mayer Ham and Cheese Loaf products due to possible cross-contamination from under-processed items.

    Product
    Kraft Heinz Foods Company — Kraft Heinz Foods Company Recalls Ready-To-Eat Ham and Cheese Loaf Products Due to Possible Cross-Contamination From Under-Processed Products
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·22V895000·2022-12-05

    Tesla Recalls 2023 Model Y Vehicles for Suspension Fastener Defect

    Tesla is recalling 2023 Model Y vehicles because front suspension fasteners may not be properly attached, which could cause instability and increase crash risk.

    Product
    TESLA — TESLA MODEL Y
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22T022000·2022-12-05

    Continental Tire Recalls Specific Models Due to Sidewall Break Risk

    Continental Tire is recalling specific 4x4 Contact, PureContact LS, and TerrainContact H/T tires because overcuring may cause sidewall breaks or tread separation, increasing crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-12052022-001·2022-12-05

    Ground Beef Alert Issued for E. Coli O157:H7 Contamination at Texas Store

    USDA FSIS issued a public health alert for ground beef sold at La Michoacana Meat Market in Greenville, Texas, after testing positive for E. coli O157:H7.

    Product
    FSIS Issues Public Health Alert for Ground Beef Products That Tested Positive for E. Coli O157:H7
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V894000·2022-12-05

    Old School Trailers Recalls 2022 Models Due to Awning Seam Defect

    Old School Trailers is recalling 2022 models because a welded seam on the electric retractable awning may separate, causing the awning to drop and increasing injury risk.

    Product
    OLD SCHOOL TRAILERS — OLD SCHOOL TRAILERS OLD SCHOOL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V892000·2022-12-02

    Pierce Recalls 2022 Fire Trucks Due to Tie Rod Clamp Cracking

    Pierce Manufacturing is recalling 2022 Saber, Enforcer, and Arrow XT fire trucks because improperly heat-treated tie rod clamps may crack, risking sudden loss of steering.

    Product
    PIERCE — PIERCE ENFORCER, ARROW XT, SABER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V893000·2022-12-02

    Terex Recalls 2022 Aerial Work Platforms Due to Boom Weld Defect

    Terex is recalling 431 units of 2022 C4000, C5000, C6000, C7000, General, and TL vehicles because a seam in the boom structure may have been improperly welded.

    Product
    TEREX — TEREX C5000, TL, C4000, C7000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23055·2022-12-01

    Gotway and Begode Unicycles Recalled for Fire Hazard

    eWheels LLC is recalling about 500 Gotway and Begode electric unicycles because their lithium-ion batteries can ignite, creating a fire hazard. Fourteen fire incidents have been reported, including property damage and one injury.

    Product
    Gotway and Begode unicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V888000·2022-12-01

    Terex Recalls 2022 Outrigger Vehicles Due to Cylinder Drift Risk

    Terex is recalling 2022 Optima TC, XT Pro, and C4000 vehicles because incorrect machining may cause outrigger cylinders to drift, increasing the risk of the machine tipping.

    Product
    TEREX — TEREX C4000, OPTIMA TC, XT PRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23712·2022-12-01

    Polaris RZR Pro XP 4 Vehicles Recalled Due to Fire Hazard

    Polaris is recalling about 600 model year 2021-2022 RZR Pro XP 4 recreational off-road vehicles because a fuel leak at the fuel pump assembly joint can occur near a hot surface, creating a fire hazard. The company has received five reports of fuel leaks, including one report of fire, but no injuries have been reported.

    Product
    Model Years 2021-2022 RZR Pro XP 4 Recreational Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide

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