The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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10726–10750 of 13816

  • 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-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
    0 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 (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
  • 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-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 (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-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 (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
  • SevereFDA (Devices)·Z-0249-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled for skin injuries and adhesive damage

    3M is recalling 248,750 Steri-Drape surgical drapes used in medical facilities worldwide. The adhesive liner is difficult to remove without damaging the product, and there are reported increases in adhesive-related skin injuries.

    Product
    3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0250-2023·2022-11-30

    3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries

    3M is recalling Steri-Drape surgical drapes (large towel drape, REF 1010) distributed worldwide. The affected drapes have reported adhesive-related skin injuries and a liner that is difficult to remove without damaging the product.

    Product
    3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0259-2023·2022-11-30

    3M Steri-Drape Medium Drape Recalled for Adhesive Skin Injuries

    3M is recalling approximately 14,360 units of Steri-Drape surgical drapes due to adhesive-related skin injuries. The product's adhesive liner is difficult to remove and may render the drape unusable.

    Product
    3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0238-2023·2022-11-30

    Mighty Bliss Electric Heating Pad recalled due to burn and shock hazard

    Whele LLC is recalling approximately 4,034 Mighty Bliss Electric Heating Pads due to burn and shock hazards. The firm received complaints of burns, mild electrical shocks, and skin irritation.

    Product
    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0261-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled due to adhesive skin injuries

    3M is recalling 103,000 units of Steri-Drape surgical drapes worldwide due to difficulties removing the adhesive liner and an increase in reported skin injuries from the adhesive.

    Product
    3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0236-2023·2022-11-30

    Mighty Bliss Electric Heating Pad recalled for burn and shock hazards

    Whele LLC is recalling the Mighty Bliss Electric Heating Pad (model MB-001) due to burn and electrical shock hazards. The firm has received complaints of burns, shocks, and skin rashes from users.

    Product
    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0264-2023·2022-11-30

    3M Urological Drape: Adhesive Liner Removal Issues and Skin Injuries

    3M has recalled 17,200 units of urological drapes due to adhesive liner removal difficulty and reported skin injuries. The affected drapes may become unusable in surgical settings.

    Product
    3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0254-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recall Due to Adhesive Injuries

    3M is recalling surgical drapes with defective adhesive components that may cause skin injuries. The adhesive liner is difficult to remove without damaging the product, and increased skin injuries have been reported.

    Product
    3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0262-2023·2022-11-30

    3M Steri-Drape General Surgery Drape Recall for Adhesive Skin Injuries

    3M is recalling 63,840 units of Steri-Drape surgical drapes worldwide due to reported adhesive-related skin injuries and defective protective liners that are difficult to remove without damaging the product.

    Product
    3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0256-2023·2022-11-30

    3M Steri-Drape Surgical Drape Recalled for Adhesive Skin Injuries

    3M Healthcare is recalling Steri-Drape surgical drapes due to an adhesive component that causes skin injuries and may render the product unusable. Affected: 104,000 units worldwide.

    Product
    3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0237-2023·2022-11-30

    Mighty Bliss Electric Heating Pad Recalled for Burn and Shock Risk

    Whele LLC is recalling the Mighty Bliss Electric Heating Pad due to burn and shock hazards. The company has received complaints of burns, electrical shocks, and skin irritation.

    Product
    Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0257-2023·2022-11-30

    3M Steri-Drape surgical drapes recalled for adhesive liner defects and skin injuries

    3M is recalling Steri-Drape surgical drapes due to a defective adhesive liner that is difficult to remove and may render the drape unusable. Reported adhesive-related skin injuries have been linked to the affected lots.

    Product
    3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0251-2023·2022-11-30

    3M Steri-Drape Surgical Drapes Recalled Due to Adhesive Defects and Skin Injuries

    3M is recalling Steri-Drape Large Towel Drapes (REF 1010NS) due to adhesive liner defects that may damage the product and increased reports of adhesive-related skin injuries from affected lots.

    Product
    3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0253-2023·2022-11-30

    3M Steri-Drape surgical drape recalled for adhesive liner defect and skin injuries

    3M is recalling 769,810 Steri-Drape surgical drapes worldwide due to a defective adhesive liner that is difficult to remove and has caused reported skin injuries.

    Product
    3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0258-2023·2022-11-30

    3M Steri-Drape Surgery Drapes Recalled for Adhesive Liner and Skin Injuries

    3M is recalling 43,200 units of Steri-Drape surgical drapes due to a difficult-to-remove adhesive liner that may damage the product and reported increases in skin injuries.

    Product
    3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
    Category
    Medical Device
    Distribution
    0 states