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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13201–13225 of 13802

  • HighFDA (Devices)·Z-2329-2021·2021-08-25

    Triathlon orthopaedic implant baseplate recalled for assembly defect

    Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.

    Product
    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2021·2021-08-25

    FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems

    Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.

    Product
    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2194-2021·2021-08-18

    HeartWare HVAD Heart Pump Recalled for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF 1104JP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2188-2021·2021-08-18

    FDA Recalls HeartWare HVAD Pump Implant Kit for Neurological Events and Mortality

    Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2195-2021·2021-08-18

    HeartWare HVAD Implant Kit Recalled Over Higher Mortality Rates

    Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.

    Product
    HeartWare HVAD Implant Kit, REF MCS1705PU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2196-2021·2021-08-18

    Heartware HVAD ventricular assist device recalled due to mortality risk

    Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.

    Product
    HeartWare HVAD Outflow Graft, REF MCS1725OG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2190-2021·2021-08-18

    HeartWare HVAD heart pump implants recalled for neurological events and mortality

    Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1125
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2193-2021·2021-08-18

    HeartWare HVAD Driveline Extension Cable Recalled for Cardiac Safety Concerns

    Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2197-2021·2021-08-18

    Heartware HVAD Pump Accessories Recalled Over Increased Mortality and Device Failures

    Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.

    Product
    HeartWare HVAD Pump Accessories, REF MCS1753AK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2192-2021·2021-08-18

    HeartWare HVAD System Recalled Due to Higher Mortality Rates

    Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.

    Product
    HeartWare HVAD Driveline Extension Cable, REF 100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2191-2021·2021-08-18

    HeartWare HVAD Pump Implant Kit Recalled for Increased Mortality and Device Failure

    Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2165-2021·2021-08-18

    Spectrum IQ Infusion Pump Safety Software Recalled for Drug Identifier Mismatch

    Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.

    Product
    Dose IQ Safety Software used with Spectrum IQ Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2021·2021-08-18

    Infusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards

    BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.

    Product
    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2110-2021·2021-08-18

    Spectrum IQ Infusion System Recalled for Connectivity Errors

    Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.

    Product
    Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2189-2021·2021-08-18

    Heart Pump Device Recalled for Increased Mortality and Device Failure

    Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.

    Product
    HeartWare HVAD Pump Implant Kit, REF 1104
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2021·2021-08-18

    Stretcher Chair Model 5050 Incorrectly Distributed to Residential Customers

    Stryker's Model 5050 stretcher chair was distributed to residential customers despite being designed for healthcare professionals. Home users may not understand instructions intended for trained medical staff, creating a risk of misuse.

    Product
    Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2251-2021·2021-08-18

    Exactech hip prosthesis femoral head labeling and marking discrepancy

    Exactech BIOLOX delta Femoral Head prosthesis components were labeled as one size but marked as a different size. This labeling discrepancy could result in implantation of the incorrect component.

    Product
    Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2205-2021·2021-08-18

    Transport Stretcher 747 distributed to home users without professional training

    Stryker's Transport Stretcher 747, designed for healthcare facilities, was distributed to home users who may not understand its intended-use instructions. The recall addresses risks from improper use by untrained consumers.

    Product
    Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2021·2021-08-18

    Stryker CUB Pediatric Crib distributed to home users instead of healthcare facilities

    Stryker's CUB Pediatric Crib, designed for hospital use by healthcare professionals, was distributed to home users who may not understand the complex instructions and safety procedures required to operate pediatric medical equipment safely.

    Product
    CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2021·2021-08-18

    Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall

    QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.

    Product
    Spectrum Medical Quantum Standard heat exchanger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2271-2021·2021-08-18

    Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

    Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2021·2021-08-18

    Medline Knee Arthroscopy Kit Recalled for Expired Irrigation Component

    Medline Industries is recalling 286 knee arthroscopy kits containing an expired NaCl irrigation bag. The kits should not be used due to the expired component.

    Product
    Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2021·2021-08-18

    Stryker Electric Hospital Beds Recalled for Unintended Home Use

    Stryker recalled 9 Electric MedSurg Bed FL23 units intended for healthcare facilities but distributed to residential customers. Professional-level instructions may not be understood by untrained home users.

    Product
    Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2021·2021-08-18

    Medtronic StimLoc Burr Hole Cover Recalled for Excess Nylon Flash on Clip

    Medtronic is recalling StimLoc Burr Hole Cover neurosurgical devices and related components due to excess nylon flash on the clip. The defect could affect device function during implantation or use.

    Product
    Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2206-2021·2021-08-18

    Stryker Surgistool Model 830 distributed to home users instead of healthcare professionals

    Stryker Medical recalls a surgical support tool that was distributed to home consumers but is intended only for healthcare professionals. The device labeling is correct, but home users may lack training to use it safely.

    Product
    Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
    Category
    Medical Device
    Distribution
    Distributed nationwide