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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11801–11825 of 27470

  • HighFDA (Devices)·Z-1514-2021·2021-05-05

    Donjoy Ultrasling Pro AB Arm Sling Recalled for Failed Rivet

    DJ Orthopedics is recalling Donjoy Ultrasling Pro AB arm slings due to a failed rivet at the chafe tab.

    Product
    DONJOY REF:11-0473-9 ULTRASLING PRO AB, UNIVERSAL, Rx ONLY, UDI: (01)00190446683681 - Product Usage: intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1476-2021·2021-04-28

    Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

    Product
    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1467-2021·2021-04-28

    AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

    AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

    Product
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1479-2021·2021-04-28

    Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.

    Product
    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1481-2021·2021-04-28

    Smiths Medical Recalls Medex Pressure Injector Lines Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of Medex pressure injector lines and related components due to insufficient or incomplete welds.

    Product
    Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1445-2021·2021-04-28

    BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion

    BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1473-2021·2021-04-28

    Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1444-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk

    Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion

    BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1468-2021·2021-04-28

    Trinity Sterile Recalls Midline Catheter Dressing Change Kits Due to Seal Defects

    Trinity Sterile, Inc. is recalling 2,970 Midline Catheter Dressing Change Kits with Statlock because evidence of foreign material in the seal caused improper sealing and compromised sterility.

    Product
    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1477-2021·2021-04-28

    Smiths Medical Recalls Stopcock Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific stopcock rotator components used in cardiac kits due to insufficient or incomplete welds.

    Product
    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1452-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 670 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1463-2021·2021-04-28

    Biotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion

    Biotronik is recalling 17 Intica Neo 7 VR-T DX DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2021·2021-04-28

    Biotronik Iforia 7 ICDs Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,176 Iforia 7 implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Iforia 7, vr-T, DX, DF-1,REF 390090, UDI: 04035479127176 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2021·2021-04-28

    Biotronik Ilestro 7 VR-T Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 1,000 Ilestro 7 VR-T implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.

    Product
    ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2021·2021-04-28

    Biotronik Ilestro 7 DR-T Recall for Premature Battery Depletion

    Biotronik is recalling Ilestro 7 DR-T implantable defibrillators due to a potential for premature battery depletion. Affected devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1453-2021·2021-04-28

    BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion

    BIOTRONIK Inc is recalling 2,881 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion.

    Product
    BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1462-2021·2021-04-28

    Biotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion

    Biotronik is recalling 74 ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1451-2021·2021-04-28

    Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik is recalling 499 ITREVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide