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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10801–10825 of 13816

  • ModerateFDA (Devices)·Z-0299-2023·2022-11-30

    Surgical convenience kits containing recalled 3M surgical drapes

    ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.

    Product
    regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0284-2023·2022-11-30

    Surgical convenience kits recalled for containing recalled 3M drapes

    Orthopedic surgical convenience kits distributed in four states were recalled because they contain 3M surgical drapes that were subject to a separate recall.

    Product
    regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0314-2023·2022-11-30

    Surgical convenience kits recalled due to included recalled drape components

    Surgical convenience kits containing 3M surgical drapes that were subsequently recalled have been pulled from distribution in LA, MO, NC, and FL. Affected lot numbers are 91465 (exp 2/7/2024) and 92444 (exp 5/5/2024).

    Product
    regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0315-2023·2022-11-30

    Eye Surgery Kit Recall Due to Defective Surgical Drapes

    ROi CPS LLC is recalling 738 regard CATARACT eye surgery convenience kits distributed in Louisiana, Missouri, North Carolina, and Florida because they contain 3M surgical drapes that have been recalled.

    Product
    regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0310-2023·2022-11-30

    Surgical Convenience Kits Recalled for Included 3M Surgical Drapes

    ROi CPS LLC is recalling 228 gastric surgery convenience kits because they contained 3M surgical drapes that were subsequently recalled. The affected kits were distributed in LA, MO, NC, and FL.

    Product
    regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0286-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Unsafe 3M Surgical Drapes

    ROi CPS LLC is recalling 18 regard KYPHOPLASTY surgical convenience kits that contained recalled 3M surgical drapes. The kits were distributed to medical facilities in Louisiana, Missouri, North Carolina, and Florida.

    Product
    regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2023·2022-11-30

    Hip Arthroscopy Surgical Convenience Kits Recalled Containing Recalled Drapes

    ROi CPS LLC is recalling Regard hip arthroscopy surgical convenience kits containing 3M surgical drapes that were subsequently recalled. The kits were distributed in LA, MO, NC, and FL.

    Product
    regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0287-2023·2022-11-30

    Surgical convenience kits recalled for containing 3M surgical drapes

    ROi CPS LLC is recalling 190 units of regard BASIC NEURO surgical convenience kits distributed in LA, MO, NC, and FL. The kits contained 3M surgical drapes that were subsequently recalled.

    Product
    regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0313-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Defective Component Drapes

    ROi CPS LLC is recalling 188 regard SPINE PACK surgical convenience kits that contain 3M surgical drapes subject to a separate FDA recall. The affected lots should be removed from use.

    Product
    regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0306-2023·2022-11-30

    Surgical Convenience Kits Containing Recalled 3M Surgical Drapes

    Eye surgery convenience kits containing 3M surgical drapes that were separately recalled are being recalled. Affected units were distributed in LA, MO, NC, and FL.

    Product
    ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0307-2023·2022-11-30

    Surgical Convenience Kits Recalled Due to Recalled 3M Surgical Drapes

    ROi CPS LLC is recalling 243 surgical convenience kits that contain recalled 3M surgical drapes. The kits were distributed in four states.

    Product
    regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0154-2023·2022-11-23

    Omnipod Dash PDM Insulin Pump Remote Recalled for Battery Fire Hazard

    Insulet Corporation is recalling the Omnipod Dash PDM remote controller for insulin pumps due to battery defects causing overheating, swelling, and fire hazard. A fire incident has been reported.

    Product
    18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2023·2022-11-23

    Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall

    Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.

    Product
    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2023·2022-11-23

    CareFusion Genesis STERRAD containers fail sterilization testing

    Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0216-2023·2022-11-23

    Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.

    Product
    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0211-2023·2022-11-23

    CareFusion sterile containers fail aerosol sterilization test requirement

    CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0232-2023·2022-11-23

    BD Phoenix diagnostic panel misformulated minocycline causes false resistance reporting

    BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.

    Product
    BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2023·2022-11-23

    125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive

    DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.

    Product
    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0207-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Required Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical instruments.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0208-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Validation Testing

    CareFusion V.Mueller GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The recall affects 319 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0231-2023·2022-11-23

    Progressa hospital bed compression links may bend during head raising

    Baxter Healthcare is recalling 248 Progressa bed systems. Compression links may bend when raising the head section, even with patients under 500 pounds.

    Product
    Hill-Rom Progressa Bed System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2023·2022-11-23

    Surgical Level 3 Gowns Recalled for Inadequate Fluid Protection

    Texas Medical Technology Inc. is recalling 100,000 Disposable Surgical Level 3 Gowns (sizes Large, XLarge, XXLarge) because the fabric fails to pass hydrostatic pressure tests, meaning blood and other body fluids may penetrate the gown.

    Product
    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2023·2022-11-23

    CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing

    CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0245-2023·2022-11-23

    Infection Control Lifting Strap Recalled for Patient Safety Risk Due to Breakage

    Tollos is recalling Infection Control (IC) Lifting Straps used with certain Cirrus and Pinnacle ceiling lifts because the straps can break during patient lifts, potentially causing patients or caregivers to be injured by falls.

    Product
    Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2023·2022-11-23

    GI4000 Electrosurgical Unit recalled due to power regulator failure risk

    Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.

    Product
    GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
    Category
    Medical Device
    Distribution
    Distributed nationwide