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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Minimum severity

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

Clear filters

14276–14300 of 27471

  • HighFDA (Devices)·Z-1222-2020·2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System because the devices may be missing the implant coil.

    Product
    Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1220-2020·2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 445 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1103-2020·2020-02-19

    Fridababy SmileFrida ToothHugger Recalled Due to Potential Metal Exposure

    Fridababy LLC is recalling SmileFrida ToothHugger toothbrushes because repeated chewing may cause the plastic head to break, exposing a small internal metal piece.

    Product
    fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2020·2020-02-19

    Blue Ortho TKA Pro Software Recalled for Incorrect Navigation Data

    Blue Ortho is recalling TKA Pro v2.1 software installed on the Exactech GPS system because it displays incorrect navigated values due to software inconsistencies.

    Product
    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
    Category
    Medical Device
    Distribution
    4 states
  • 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-0955-2020·2020-02-19

    Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

    Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
    Category
    Medical Device
    Distribution
    52 states
  • 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-0930-2020·2020-02-19

    Tytek Medical Recalls PneumoDart Devices Due to Occluded Needle Defect

    Tytek Medical Inc is recalling 3,565 PneumoDart devices because a defect involving an occluded needle was discovered during a training exercise.

    Product
    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
    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-1112-2020·2020-02-19

    Teleflex Medical Recalls Hudson RCI Comfort Flo Humidifier Nebulizer Kits

    Teleflex Medical is recalling 30,566 Hudson RCI Comfort Flo humidifier nebulizer kits because water may flood the column and enter the circuit during high-flow oxygen therapy.

    Product
    HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
    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-1113-2020·2020-02-19

    Teleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems

    Teleflex Medical is recalling 60,467 Hudson RCI Comfort Flo Corrugated Humidification Systems because water may flood the column and enter the circuit during high-flow oxygen therapy.

    Product
    HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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