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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19001–19025 of 27647

  • HighFDA (Devices)·Z-0145-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility

    Exactech, Inc. is recalling 306 Optetrak Offset Tibial Trays and Screws because a design incompatibility exists between certain screw sizes and tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0164-2018·2017-11-29

    Medline Transfer/Gait Belt Recall Due to Locking Mechanism Failure

    Medline Industries is recalling 1,428 Transfer/Gait Belts because the locking mechanism may fail to secure the strap, allowing it to slip through the buckle.

    Product
    Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2018·2017-11-29

    3M Recalls Bair Hugger Temperature Sensors Due to Programming Error

    3M is recalling Bair Hugger temperature sensors because a programming error may cause the device to display a temperature lower than the patient's actual body temperature.

    Product
    3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0106-2018·2017-11-29

    ICU Medical Recalls IV Sets with Potential Metallic Burrs in Stopcocks

    ICU Medical is recalling specific IV administration sets because stopcocks may contain metallic burrs. The recall covers 24,475 units distributed in the US and Thailand.

    Product
    SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0131-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility

    Exactech, Inc. is recalling 640 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0110-2018·2017-11-29

    Medtronic MiniMed Mio Infusion Sets Recalled for Potential Insulin Over-Delivery

    Medtronic is recalling MiniMed Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0159-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 678 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0115-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Error

    Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.

    Product
    ROSA Surgical Device 2.5.8
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0162-2018·2017-11-29

    Medline Recalls Sensicare Green Surgical Gloves Due to Potential Sterility Breach

    Medline Industries is recalling 8,000 units of Sensicare Green Surgical Gloves because a possible open seal on the packaging could compromise sterility.

    Product
    Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile. Surgical glove.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0109-2018·2017-11-29

    Medtronic MiniMed Sure-T Infusion Sets Recalled for Insulin Over-Delivery Risk

    Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.

    Product
    Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0130-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 207 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0142-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 311 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0118-2018·2017-11-29

    Halyard Turbo-Cleaning Closed Suction System Recalled for Leaking Saline Vials

    Halyard Health is recalling Turbo-Cleaning Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0136-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 683 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0129-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 198 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0166-2018·2017-11-29

    Abbott Peristaltic Head Tubing Recalled for Potential Leaking

    Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.

    Product
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0117-2018·2017-11-29

    Halyard Closed Suction System Recalled for Potential Saline Vial Leaking

    Halyard Health is recalling specific lots of Closed Suction Systems because saline vials may leak, potentially exposing contents to infectious agents.

    Product
    Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0138-2018·2017-11-29

    Exactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility

    Exactech is recalling 527 Optetrak Offset Tibial Tray and Screws units due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.

    Product
    Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0107-2018·2017-11-29

    Medtronic MiniMed Quick-set Infusion Sets Recalled for Insulin Over-delivery Risk

    Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
    Category
    Medical Device
    Distribution
    0 states