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 13717

  • HighFDA (Devices)·Z-0240-2023·2022-11-23

    Simplex HV bone cement distributed under wrong part number

    Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.

    Product
    Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
    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-0206-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
    Category
    Medical Device
    Distribution
    0 states
  • 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-0218-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing

    Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.

    Product
    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0210-2023·2022-11-23

    CareFusion Genesis sterilization containers recalled for failed sterility testing

    CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0221-2023·2022-11-23

    Philips Laser System may enter non-recoverable error state

    The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.

    Product
    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
    Category
    Medical Device
    Distribution
    30 states
  • 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-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-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-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-0204-2023·2022-11-23

    CareFusion Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed required aerosol challenge testing. The 1,143 affected units may not adequately sterilize surgical instruments.

    Product
    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • 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-0230-2023·2022-11-23

    Spinal Decompression System Recalled for Potential Weld Breakage

    Boston Scientific is recalling 175 Superion Indirect Decompression System devices due to potential weld breakage at the spindle cap that may prevent proper deployment during implantation.

    Product
    Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2023·2022-11-23

    CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements

    Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.

    Product
    CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
    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-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-0243-2023·2022-11-23

    EasyStand Bantam standing devices may fail to maintain upright position

    Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.

    Product
    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0200-2023·2022-11-23

    Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use

    Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.

    Product
    Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2023·2022-11-23

    OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure

    Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.

    Product
    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2023·2022-11-23

    Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns

    Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.

    Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0215-2023·2022-11-23

    GENESIS Full-Length Sterilization Containers recalled for failed aerosol testing

    CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2023·2022-11-23

    CareFusion Genesis Mini Sterilization Containers fail aerosol testing

    CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.

    Product
    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
    Category
    Medical Device
    Distribution
    0 states
  • 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