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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22626–22650 of 27699

  • HighFDA (Devices)·Z-0142-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling iDuo Bicompartmental Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 603 units of the MOSAICPLASTY DP Disposable Harvesting System because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2016·2015-10-28

    ConFormis iDUO G2 Knee Implant Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2 knee implant due to potential ethylene glycol residue.

    Product
    ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2016·2015-10-28

    ConForMIS iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 313 units of the iTotal CR Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2016·2015-10-28

    Baxter Recalls Microbore Catheter Extension Sets Due to Potential Leak

    Baxter Healthcare Corp is recalling 23,600 units of One-Link Microbore Catheter Extension Sets due to a potential leak at the tubing to luer bond.

    Product
    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0141-2016·2015-10-28

    ConForMIS iUni Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 68 iUni Unicondylar Knee Replacement Systems due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2016·2015-10-28

    ConForMIS iUni Knee Replacement System Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 7 units of the iUni Unicondylar Knee Replacement System due to potential small amounts of ethylene glycol residue.

    Product
    ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling 1,347 units of the MOSAICPLASTY DP- Disposable Harvesting System because a packaging breach compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2016·2015-10-28

    Cardinal Health Recalls Ambitex NMD400 Nitrile Exam Gloves Due to Leak Test Failure

    Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves (size medium) because samples failed FDA water leak tests, compromising their barrier function.

    Product
    Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0154-2016·2015-10-28

    Berchtold TELETOM Equipment Management System Recall for Control Malfunction

    Berchtold Corp. is recalling TELETOM Equipment Management Systems 4 and 6 series due to potential control and brake failure caused by fluid intrusion.

    Product
    TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2016·2015-10-28

    Smith & Nephew MOSAICPLASTY Harvesting System Recalled for Packaging Breach

    Smith & Nephew is recalling MOSAICPLASTY DP- Disposable Harvesting Systems because a breach in the packaging compromised the device's sterility.

    Product
    Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2016·2015-10-21

    Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.

    Product
    Inserter for Titanium Elastic Nails (TEN), orthopedic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2016·2015-10-21

    ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement

    ViewRay is recalling four MRIdian Radiation Therapy Systems because the patient couch may move unexpectedly if an encoder fails and the system is restarted.

    Product
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0119-2016·2015-10-21

    Zimmer Natural Nail CM Long Intramedullary Fixation Rods Recalled for Packaging Defects

    Zimmer GmbH is recalling 57,603 units of Natural Nail CM Long intramedullary fixation rods because compromised outer trays may lead to periprosthetic infection.

    Product
    Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2016·2015-10-21

    DJO Monode Shortwave Accessory Recalled for Overheating and Burning Insulation

    DJO, LLC is recalling Monode Shortwave Accessories due to overheating and burning of the wire insulation inside the applicator.

    Product
    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2016·2015-10-21

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.

    Product
    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0059-2016·2015-10-14

    FDA Recalls 726 Sterile Laparoscopic Cholecystectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 726 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0111-2016·2015-10-14

    DePuy Orthopaedics Recalls Specialist 2 Intramedullary Rod Instruments Due to Fracture Complaints

    DePuy Orthopaedics is voluntarily recalling select lots of the Specialist 2 Intramedullary Rod 400mm Instrument because the rod has fractured, leaving portions inside patients.

    Product
    Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with…
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-0082-2016·2015-10-14

    FDA Recalls Pacemaker Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 40 pacemaker surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0033-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0074-2016·2015-10-14

    FDA Recalls Robotic Laparoscopic Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 144 robotic laparoscopic surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0075-2016·2015-10-14

    FDA Recalls 64 Sterile Peripheral Vascular Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 64 sterile surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0092-2016·2015-10-14

    FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 214 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0078-2016·2015-10-14

    FDA Recalls 24 Sterile Breast Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 24 sterile breast surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0052-2016·2015-10-14

    Resource Optimization & Innovation Recalls Vaginal Hysterectomy Surgical Kits

    Resource Optimization & Innovation LLC is recalling 36 vaginal hysterectomy surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states