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.

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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

18226–18250 of 40124

  • HighFDA (Devices)·Z-1106-2020·2020-02-19

    Cardiac Assist Recalls TandemLife ECLS Procedure Kits with Incorrect Cannula

    Cardiac Assist, Inc. is recalling 11 TandemLife ECLS Procedure Kits that contained a 29Fr ProtekDuo cannula instead of the intended 24Fr Protek Solo Venous cannula.

    Product
    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2020·2020-02-19

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for Potential Sodium Bias

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 units due to a potential for negatively biased sodium (Na+) urine results.

    Product
    VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2020·2020-02-19

    Flowonix Prometra Programmable 20mL Pump Recalled for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL Pumps because a firmware anomaly may prevent the device from sending error notifications or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2020·2020-02-19

    MicroVention AZUR Peripheral Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 107 units of the AZUR Peripheral Coil System because the implant coil may be missing from the sterile packaging.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1122-2020·2020-02-19

    Flowonix Prometra II Pump Recall for Firmware Alarm Defect

    Flowonix Medical Inc is recalling Prometra II 40mL implantable infusion pumps because a firmware anomaly may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code ASK-05503-BID
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1145-2020·2020-02-19

    Philips VesselNavigator Software Recall for DSA Display Defect

    Philips is recalling VesselNavigator software due to a defect that displays digital subtraction angiography images without subtraction.

    Product
    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2020·2020-02-19

    Respironics V60 Ventilator Recalled for Frozen Touchscreen Failure

    Respironics is recalling 2,851 V60 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings. This could delay necessary changes, potentially leading to hypercarbia or hypoxemia.

    Product
    Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2020·2020-02-19

    Terumo Advanced Perfusion System 1 Roller Pump Recall for Shaft Failure

    Terumo is recalling 106 Advanced Perfusion System 1 Roller Pumps because the pump shafts may fail, potentially causing the pump to stop during surgery.

    Product
    Terumo Advanced Perfusion System 1 Roller Pump, 6 Inch, Catalog Number 816571 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Sets

    Arrow International is recalling FlexTip Plus Epidural Catheterization Sets because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Set, Product Code JC-05400-DCS
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1104-2020·2020-02-19

    Dexcom G6 CGM App iOS Software Recall for Low Alarm Defect

    Dexcom Inc is recalling the Dexcom G6 CGM App for iOS due to a software defect that may prevent low blood glucose alarms from triggering correctly.

    Product
    Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1124-2020·2020-02-19

    Flowonix Prometra Implantable Pump Recall for Firmware Alarm Anomaly

    Flowonix Medical Inc is recalling Prometra Programmable 20mL implantable infusion pumps due to a firmware defect that may prevent the device from sending error codes or audible alarms during valve system issues.

    Product
    Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2020·2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 19 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1148-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 87 Omega 4.75 mm PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1150-2020·2020-02-19

    Medtech ROSA Brain 3.0 Software Recalled for Image Reconstruction Errors

    Medtech SAS is recalling ROSA Brain 3.0 software because cross-sectional images may not display properly, potentially compromising surgery planning.

    Product
    ROSA Brain 3.0 Application-Brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2020·2020-02-19

    Stryker Omega PEEK Knotless Anchor System Recalled for Driver Removal Issues

    Stryker is recalling 73 Omega PEEK Knotless Anchor Systems because high driver removal forces can cause the screw to pull out of the bone.

    Product
    Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1154-2020·2020-02-19

    Respironics Ventilator Touchscreen Recall Due to Unresponsive Controls

    Respironics is recalling V60/V680 ventilator touchscreens that may freeze and fail to respond to touch commands, potentially delaying necessary therapy adjustments.

    Product
    Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2020·2020-02-19

    bioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits

    bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.

    Product
    VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2020·2020-02-19

    Respironics V680 Ventilator Recalled for Unresponsive Touchscreen

    Respironics is recalling 190 V680 Ventilators because the touchscreen may freeze, preventing clinicians from adjusting therapy settings and potentially causing delayed treatment.

    Product
    Respironics V680 Ventilator, Service # 850011, (OUS Only)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2020·2020-02-19

    Arrow International Recalls FlexTip Plus Epidural Catheterization Kits

    Arrow International is recalling FlexTip Plus Epidural Catheterization Kits because the included syringes may fail, potentially causing dural puncture.

    Product
    FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1126-2020·2020-02-19

    Implant Direct Sybron Recalls Dental Implants With Incorrect Color Coding

    Implant Direct Sybron Manufacturing LLC is recalling 11 dental implant units because the vial and cap colors did not match the implant size, potentially causing surgical delays or infection risks.

    Product
    SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
    Category
    Medical Device
    Distribution
    0 states