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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3826–3850 of 5111

  • CriticalFDA (Devices)·Z-0659-2017·2016-12-14

    SynCardia Freedom Driver System Recalled for Potential Silent Failure

    SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.

    Product
    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0178-2017·2016-12-14

    North American Rescue Recalls Advance Trauma Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Advance Trauma Kits because the manufacturer has concerns regarding the sterility of the eye wash irrigating solution.

    Product
    Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0181-2017·2016-12-14

    North American Rescue Recalls Mini Resupply Trauma Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Mini Resupply Trauma Kits because the manufacturer has concerns about the sterility of the included eye wash solution.

    Product
    Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0177-2017·2016-12-14

    North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Range Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.

    Product
    Range Trauma Kit - Product Code 85-1274, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0175-2017·2016-12-14

    North American Rescue Recalls Range Trauma Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Range Trauma Kit Hardcases because the manufacturer has concerns about the sterility of the eye wash irrigating solution included in the kits.

    Product
    Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2017·2016-12-14

    North American Rescue Recalls K-9 Trauma Field Kits Due to Sterility Concerns

    North American Rescue LLC is recalling K-9 Trauma Field Kits because the manufacturer has concerns about the sterility of the included eye wash irrigating solution.

    Product
    K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0182-2017·2016-12-14

    North American Rescue Recalls Aid Backpack Kits Due to Sterility Concerns

    North American Rescue LLC is recalling Aid Backpack Kits because the manufacturer has concerns about the sterility of the eye wash irrigating solution.

    Product
    Aid Backpack Kit - Product Code 85-0917, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0183-2017·2016-12-14

    North American Rescue Recalls USCG Boat Response Kits Due to Sterility Concerns

    North American Rescue LLC is recalling USCG Boat Response Kits because the manufacturer has concerns about the sterility of the eye wash irrigating solution.

    Product
    USCG Boat Response Kit - Product Code 80-0353, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0727-2017·2016-12-14

    AMD-Ritmed Transparent Dressing Recalled for Sterility Failure

    AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.

    Product
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0701-2017·2016-12-14

    3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect

    3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.

    Product
    3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DW
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0702-2017·2016-12-14

    Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning

    Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.

    Product
    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0180-2017·2016-12-14

    North American Rescue Recalls Amphibious Trauma Kits Due to Sterility Concerns

    North American Rescue is recalling Amphibious Trauma Kits because the manufacturer has concerns about the sterility of the eye wash solution.

    Product
    Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0660-2017·2016-12-07

    Elekta Monaco RTP System Recalled for Incorrect Dose Calculation

    Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.

    Product
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0653-2017·2016-11-30

    AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk

    AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.

    Product
    COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when con
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0487-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 205 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0307-2017·2016-11-16

    FDA Recalls Pipeline Embolization Devices Due to Coating Delamination

    Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.

    Product
    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0308-2017·2016-11-16

    Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect

    Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.

    Product
    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2017·2016-11-16

    Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure

    Stryker Howmedica Osteonics is recalling specific lots of LFIT Anatomic V40 Femoral Heads because of reported taper lock failures that caused harm.

    Product
    LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0310-2017·2016-11-16

    Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires

    Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.

    Product
    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2017·2016-11-16

    Siemens SOMATOM Definition AS CT Systems Recalled for Injury Risk

    Siemens Medical Solutions is recalling 57 SOMATOM Definition AS CT systems due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition AS system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2017·2016-11-16

    Siemens SOMATOM Definition Flash CT Systems Recalled for Injury Risk

    Siemens is recalling 57 SOMATOM Definition Flash CT systems in the US due to a hardware issue that may expose users to rotating or electrical parts.

    Product
    SOMATOM Definition Flash system, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2017·2016-11-09

    Battle Creek Thermophore Deep-Heat Therapy Devices Recalled for Fire Risk

    Battle Creek Equipment Co. is recalling Thermophore Classic and Plus deep-heat therapy devices because the power cord can spark, causing smoke, fire, and burns.

    Product
    Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Professional Quality Deep-Heat Therapy, Model 056 Medium 14" x 14", Model 077: Thermophore Classic Professional Quality Deep-Heat Therapy, Mo
    Category
    Medical Device
    Distribution
    1 state