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 the agency’s own highest classification or reported deaths or serious injuries, 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

Agency

Category

Minimum severity

Clear filters

11901–11925 of 39932

  • HighFDA (Devices)·Z-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2022·2022-09-07

    AggreGuide A-100 Instrument Software Issue Affecting Test Results

    Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.

    Product
    AggreGuide A-100 Instrument
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1642-2022·2022-09-07

    T-Cell Xtend Test Kit Recalled Due to Improper Storage Temperature

    Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.

    Product
    T-Cell Xtend REF TTK.610 US
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1638-2022·2022-09-07

    Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion

    Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.

    Product
    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1650-2022·2022-09-07

    FGFR cancer diagnostic kit recalled due to increased false positive results

    Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.

    Product
    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1643-2022·2022-09-07

    Cell culture medium recalled for improper storage temperature conditions

    Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.

    Product
    AIM-V Medium REF AV.200/500
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1668-2022·2022-09-07

    DeRoyal Sterile Custom Kits Recalled for Defective Connectors

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.

    Product
    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1640-2022·2022-09-07

    bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies

    bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.

    Product
    VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1646-2022·2022-09-07

    X-ray imaging system hardware defect may prevent operation

    Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.

    Product
    Artis pheno- Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1561-2022·2022-08-31

    Diaphragm pacing system external pulse generator recalled for circuit board defect

    Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.

    Product
    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2022·2022-08-31

    McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.

    Product
    a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2022·2022-08-31

    Central Venous Catheter Kits Recalled for Potential Temperature Damage

    McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.

    Product
    TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1562-2022·2022-08-31

    DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

    DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

    Product
    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1571-2022·2022-08-31

    Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators

    The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.

    Product
    Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2022·2022-08-31

    Surgical ophthalmic wicks recalled for potential effectiveness loss

    McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2022·2022-08-31

    B. Braun Gravity Mixing Container Recalled for Temperature Exposure

    B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.

    Product
    B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2022·2022-08-31

    Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss

    Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.

    Product
    BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2022·2022-08-31

    Perifix LOR Syringes Recalled Due to Temperature Exposure During Storage

    Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.

    Product
    Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2022·2022-08-31

    Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage

    Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2022·2022-08-31

    Medical Device Recall: Wetfield Eraser Bipolar Hemostatic due to temperature exposure

    McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.

    Product
    Wetfield Eraser Bipolar Hemostatic Eraser Wet-Field Eraser 23 Gauge Tapered Model Number: 221265
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2022·2022-08-31

    Medical device recall for temperature exposure during storage

    McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.

    Product
    a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST…
    Category
    Medical Device
    Distribution
    Distributed nationwide