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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8301–8325 of 13683

  • SevereFDA (Devices)·Z-2530-2023·2023-09-27

    Ventilator Spare Parts Recalled for Degrading Capacitor Risk

    Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.

    Product
    Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2023·2023-09-27

    Orthopedic implant components recalled due to sterilization failure

    Encore Medical is recalling 15 orthopedic implants (DJO Surgical Altivate Reverse) due to sterilization failure. If implanted, unsterilized components may cause infection requiring treatment, monitoring, or revision surgery.

    Product
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2599-2023·2023-09-27

    Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

    Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2023·2023-09-27

    Stryker bone cement cartridge nozzles may disassemble during surgical use

    Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2023·2023-09-27

    Stryker ACM System nozzle may disassemble during bone cement mixing

    The break-away femoral nozzle in Stryker's ACM System may disassemble during use, potentially leaving fragments in the surgical site and causing device failure.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows the user to mix bone cement with a constant high vacuum through the process. Catalog Number: 0306-705-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2023·2023-09-27

    VITROS XT Chemistry TBIL-ALKP Slides recalled for incorrect liver enzyme readings

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2605-2023·2023-09-27

    Orthopedic hip stem implant recalled due to sterilization failure

    Encore Medical has recalled a hip stem orthopedic implant that was not sterilized before shipment. Non-sterile implants may cause infection if implanted, requiring treatment and potentially revision surgery.

    Product
    DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2608-2023·2023-09-27

    Philips Patient Information Center iX Software Crashes Delay Patient Monitoring

    Philips Patient Information Center iX software versions 4.x may crash due to an Intel Graphics Driver error, causing a blank screen. Users must manually reboot the system, potentially delaying the detection of patient condition changes.

    Product
    Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) Patient Information Center iX Expand Product Number: 866390; (3) PIC iX Essentials Product Number: 867093; (4) PIC iX Essential
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2604-2023·2023-09-27

    DJO Surgical Orthopedic Implants Recalled for Sterilization Failure

    DJO Surgical orthopedic implants (lot 878B1171) were shipped without sterilization and may cause infection if implanted, potentially requiring treatment, monitoring, or revision surgery. Contact your healthcare provider to verify your lot number.

    Product
    DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2600-2023·2023-09-27

    Stryker ACM Cement Mixing System nozzle may break during surgery

    Stryker is recalling ACM Systems due to potential breakage of the femoral nozzle applicator tip during use. This could cause device failure and leave components in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-573-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2023·2023-09-27

    Smith & Nephew knee implant recall: wrong size in packaging

    Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.

    Product
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2595-2023·2023-09-27

    Medline Iris Scissors Recalled Due to Detachable Tip Protector Risk

    Medline is recalling 324,451 sterile iris scissors because the tip protector may detach, exposing a sharp point that could puncture sterile packaging and compromise instrument sterility.

    Product
    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2023·2023-09-27

    APK2 Wheelchair Cushion Battery Pack Defect Can Cause Overheating

    Aquila Corporation recalls 117 APK2 wheelchair cushions with defective battery packs that can overheat. The risk could result in property damage and injury.

    Product
    APK2 Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2023·2023-09-27

    Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery

    Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.

    Product
    Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2614-2023·2023-09-27

    Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure

    Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.

    Product
    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2606-2023·2023-09-27

    DJO Surgical Reverse Shoulder System Components Recalled Due to Missing Sterilization

    Reverse shoulder implant components were shipped without final sterilization, potentially leading to infection and possible revision surgery if implanted. Encore Medical is recalling 64 units distributed across the US and internationally.

    Product
    DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2620-2023·2023-09-27

    Copan Transfer Pipette Recalled Due to Plastic Defects

    Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.

    Product
    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2624-2023·2023-09-27

    FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.

    Product
    VITROS XT Chemistry Products ALKP Slides
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2023·2023-09-27

    SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk

    Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.

    Product
    SofTech Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2023·2023-09-27

    Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble

    Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2023·2023-09-27

    TyTek PneumoDart Decompression Device: Updated Instructions for Needle Placement

    Tytek Medical is updating instructions for the TyTek PneumoDart to better identify needle decompression risks and improve placement guidance. Approximately 22,026 units distributed before October 5, 2020 are affected.

    Product
    TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2617-2023·2023-09-27

    PDS II Surgical Sutures Recalled for Tensile Strength Defect

    ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.

    Product
    PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
    Category
    Medical Device
    Distribution
    Distributed nationwide