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

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4401–4425 of 39987

  • HighFDA (Devices)·Z-1320-2025·2025-03-19

    ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity

    ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1319-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2025·2025-03-19

    GE Healthcare CT Systems May Leak Coolant Fluid on Floor

    GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.

    Product
    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1302-2025·2025-03-19

    GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk

    GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.

    Product
    GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1317-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure

    ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1316-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Conditions

    The ZOLL Powerheart G5 automated external defibrillator may fail its self-test after prolonged exposure to extreme temperatures or humidity levels. This could prevent proper device functioning in an emergency.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2025·2025-03-19

    GE Healthcare Revolution CT systems recalled for potential coolant leaks

    GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.

    Product
    GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1244-2025·2025-03-12

    Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk

    Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.

    Product
    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1257-2025·2025-03-12

    Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

    Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

    Product
    Paradigm insulin pump, REF: MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1263-2025·2025-03-12

    Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes

    Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1253-2025·2025-03-12

    Baxter Sigma Spectrum Infusion System Recalled for Missing Mounting Screws

    Baxter Healthcare is recalling 66 units of Sigma Spectrum Infusion System (V6) due to potential missing motor mounting screws that may have occurred during servicing. Missing screws could affect the device's operation.

    Product
    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1246-2025·2025-03-12

    Medtronic Pipeline Vantage device recall: deformation may cause blood clots

    The Pipeline Vantage Embolization Device may malfunction, with the braid deforming or not positioning correctly, potentially causing blood clots. Approximately 7,820 units are affected worldwide.

    Product
    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1245-2025·2025-03-12

    Medtronic Pipeline Vantage Embolization Device Recall for Structural Deformation Risk

    Medtronic is recalling approximately 18,245 unused Pipeline Vantage embolization devices due to incomplete wall apposition and braid deformation that may lead to thrombosis and serious adverse events.

    Product
    Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1254-2025·2025-03-12

    Baxter Spectrum IQ Infusion System may have missing motor mounting screws

    Baxter Spectrum IQ Infusion Systems may lack motor mounting screws due to a servicing defect. The FDA Class I recall affects 323 units distributed nationwide.

    Product
    Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1205-2025·2025-03-12

    FDA Recalls VARIPULSE Bi-Directional Ablation Catheter Due to Neurovascular Events

    Biosense Webster is recalling VARIPULSE Bi-Directional Ablation Catheters (REF D141201) due to an observed trend of neurovascular events. The FDA issued a Class I recall affecting approximately 497 units distributed worldwide.

    Product
    VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomat
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1291-2025·2025-03-12

    DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues

    DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.

    Product
    DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1269-2025·2025-03-12

    CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction

    Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.

    Product
    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2025·2025-03-12

    MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight

    MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.

    Product
    MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2025·2025-03-12

    Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight

    Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2025·2025-03-12

    Medtronic MiniMed insulin pump recalled for air pressure-triggered delivery defect

    Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.

    Product
    MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2025·2025-03-12

    MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight

    Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.

    Product
    MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2025·2025-03-12

    Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes

    Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2025·2025-03-12

    Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex

    Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.

    Product
    Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2025·2025-03-12

    Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes

    Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    Category
    Medical Device
    Distribution
    Distributed nationwide