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.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

9126–9150 of 40056

  • HighFDA (Devices)·Z-2633-2023·2023-10-04

    exoplan 3.1 Dental Software Filtering Error Affects Surgical Guide Planning

    Dental planning software exoplan 3.1 contains a filtering error that may display all surgical guide options instead of only supported ones, potentially causing patient injury.

    Product
    exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2023·2023-10-04

    Aquilex Fluid Control System May Cause Fluid Overload During Hysteroscopy

    The Aquilex Fluid Control System (Models AQL-100PBS, AQL-100P) display may freeze at maximum volume (30,000 ml) during long procedures, causing inaccurate fluid monitoring and potential fluid overload.

    Product
    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2023·2023-10-04

    ProSun Luxura Vegaz Model 52X UV Tanning Device Safety Circuit Defect Recall

    J&T Health and Wellness LLC recalls the ProSun Luxura Vegaz Model 52X ultraviolet tanning device due to a potential safety circuit defect. A communication isolator may cause a disturbance that compromises the safety circuit.

    Product
    ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2644-2023·2023-10-04

    B.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall

    B.Braun NORM-JECT Luer Lock Solo 10ml sterile syringes are being recalled because the sterile blister packaging may be damaged, potentially compromising sterility. The recall affects 604,800 units distributed nationwide.

    Product
    B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2023·2023-10-04

    B. Braun NORM-JECT Sterile Syringes Recalled Due to Packaging Damage

    B. Braun NORM-JECT Luer Solo 10 ml sterile syringes are recalled because blister packaging may be damaged, potentially compromising sterility. Approximately 534,000 units are affected; lot numbers 22M28C8 and 23A09C8 are included.

    Product
    B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2023·2023-10-04

    Baxter Epiphany Cardio Server E3 Caliper Tool Non-Responsive in ECG System

    Baxter Healthcare issued an urgent correction for the Epiphany Cardio Server E3 ECG Management System because the caliper tool may become non-responsive, temporarily preventing its use. Affects 89 units distributed across the US, Canada, and Bermuda.

    Product
    Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • SevereFDA (Devices)·Z-2529-2023·2023-09-27

    Ventilator Control Board Spare Parts Recalled Due to Electrical Short-Circuit Risk

    Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.

    Product
    Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2528-2023·2023-09-27

    Intensive Care Ventilators Recalled Due to Capacitor Degradation Risk

    Hamilton Medical is recalling 12 intensive care ventilators (model Hamilton-MR1) due to degrading capacitors that may leak electrolyte, potentially causing ventilation interruption. The recall affects specific serial numbers across the US and Puerto Rico.

    Product
    Hamilton-MR1, REF: 161010, Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2023·2023-09-27

    Hamilton-T1 Ventilator Recall: Degrading Capacitors May Interrupt Ventilation

    Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.

    Product
    Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2525-2023·2023-09-27

    Portable Intensive Care Ventilator Recalled for Degrading Capacitor Issue

    Hamilton Medical is recalling 164 Hamilton-C1 portable ventilators due to degrading capacitors that may leak electrolyte, causing electrical short circuits that could interrupt ventilation.

    Product
    Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2615-2023·2023-09-27

    Abbott Implantable Defibrillator Devices Recalled for Bluetooth Malfunction

    Abbott is recalling certain implantable defibrillator devices manufactured before April 2022 due to a Bluetooth malfunction that results in loss of wireless communication and potential excessive battery drain.

    Product
    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary f
    Category
    Medical Device
    Distribution
    0 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-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-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-2601-2023·2023-09-27

    Stryker ACM System Femoral Nozzle Recall for Potential Disassembly

    Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
    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-2616-2023·2023-09-27

    PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect

    Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.

    Product
    PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2626-2023·2023-09-27

    FLUIDSHIELD 3 N95 Mask Filtration Failure (Lot AM2164811)

    O&M Halyard recalls FLUIDSHIELD 3 N95 masks in orange size small (Lot AM2164811) after one sample failed filtration efficiency testing. The affected masks may not provide adequate respiratory protection.

    Product
    FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827
    Category
    Medical Device
    Distribution
    11 states
  • 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-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-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-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