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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

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

Clear filters

27551–27575 of 27681

  • HighFDA (Devices)·Z-1972-2012·2012-07-18

    GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues

    Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.

    Product
    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2012·2012-07-18

    Abbott i-STAT1 Abaxis Analyzer Recalled for Overheating Battery Area

    Abbott Point of Care is recalling i-STAT1 Abaxis Analyzers because the battery area can become uncomfortably hot to touch.

    Product
    i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2012·2012-07-18

    Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms

    Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.

    Product
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1986-2012·2012-07-18

    Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure

    Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.

    Product
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1970-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2012·2012-07-18

    Atom Medical Infant Incubator Model 100 Recalled for Canopy Movement

    Atom Medical Corporation is recalling 377 Dual Incu i infant incubators because the canopy may move unintentionally during use.

    Product
    Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1959-2012·2012-07-18

    Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.

    Product
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1944-2012·2012-07-18

    Impac Medical MOSAIQ Oncology System Recall for Wedge Motor Unit Error

    Impac Medical is recalling MOSAIQ Oncology Information Systems due to a software error that incorrectly resets remaining Wedge Motor Units to zero after a machine fault.

    Product
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2007-2012·2012-07-18

    Elekta Monaco Software Recall for Incorrect Patient Shift Directions

    Elekta, Inc. is recalling Monaco radiation therapy planning software versions 3.10.00 through 3.20.00 due to a defect that prints incorrect patient shift directions when specific DICOM options are enabled.

    Product
    Monaco Product Usage: Planning of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Central Control Module Recall

    Terumo is recalling 648 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.

    Product
    Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump occlusion malfunctions that could prevent pump use.

    Product
    System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions

    Terumo CVS is recalling 648 units of the Advanced Perfusion System 1 due to roller pump malfunctions that may require replacement with back-up equipment during procedures.

    Product
    System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1949-2012·2012-07-18

    Arjo Sara Plus Patient Lifter Recalled for Exposed Metal Bracket Injury Risk

    ArjoHuntleigh is recalling Sara Plus Mobile Patient Lifters because removing the knee pad assembly exposes a metal support bracket, posing an injury risk.

    Product
    Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues

    Terumo is recalling approximately 632 System 1 Base units because the backup battery depletes faster than expected, potentially causing unexpected system shutdowns.

    Product
    System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1982-2012·2012-07-18

    Stryker Definition PM Femoral Hip Stem Recalled for PMMA Coating Cracking

    Stryker Howmedica Osteonics is recalling 16,913 Definition PM Femoral Hip Stems due to potential cracking of the PMMA coating. The devices were distributed nationwide.

    Product
    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2012·2012-07-11

    CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1937-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 683 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage during use.

    Product
    Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1940-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.

    Product
    Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1938-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2012·2012-07-11

    DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1899-2012·2012-07-11

    CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter

    CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.

    Product
    AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1905-2012·2012-07-11

    Invacare Recalls TDX Power Wheelchairs Due to Fire and Injury Risk

    Invacare is recalling specific TDX power wheelchairs because a defect in the post fuse assembly could cause a short circuit, leading to fire and serious injury.

    Product
    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1923-2012·2012-07-11

    DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations

    DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.

    Product
    LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1939-2012·2012-07-11

    DePuy Spine Side Fire Needles Recalled for Breakage Reports

    DePuy Mitek is recalling 530 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.

    Product
    Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide