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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Minimum severity

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

Clear filters

40326–40350 of 40356

  • ModerateFDA (Devices)·Z-1819-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2012·2012-06-27

    Accumetrics Recalls VerifyNow System for P2Y12 Test Result Changes

    Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.

    Product
    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1825-2012·2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1814-2012·2012-06-27

    Tripath Imaging Recalls 480 Test Kits Due to Leaking Pipettes

    Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.

    Product
    Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1815-2012·2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.

    Product
    PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2012·2012-06-20

    Baxter Sigma Spectrum Infusion Pump Recall for Bearing Failure Risk

    Baxter Healthcare is recalling 63,225 Sigma Spectrum Infusion Pumps because bearing lubricant loss can cause flow failures and potential over-infusion.

    Product
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2012·2012-06-20

    Stryker T4-Hytrel Zipper Toga Recall Due to Missing Tape

    Stryker is recalling T4-Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2012·2012-06-20

    Stryker T5 Hytrel Zipper Toga Recalled for Missing Protective Tape

    Stryker is recalling T5 Hytrel Zipper Togas because clear tape was not applied during manufacturing, allowing bodily fluids to bleed through the sleeve seam.

    Product
    T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2012·2012-06-20

    GE Healthcare Revolution XR/d Recalled for Finger Pinch Hazard

    General Electric is recalling 3,796 Revolution XR/d digital radiographic imaging systems worldwide due to a reported incident where an operator's finger was pinched.

    Product
    GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1789-2012·2012-06-20

    GE Healthcare Definium 8000 Digital Radiographic Systems Recalled for Pinch Hazard

    General Electric is recalling 3,796 Definium 8000 Digital Radiographic Systems because an operator's finger was pinched between the fixed roller and the gliding tabletop.

    Product
    GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model Number: 5131070. The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1792-2012·2012-06-20

    MicroAire Lipofilter 3000 Canisters Recalled for Sterilization Defects

    MicroAire Surgical Instruments is recalling 15 Lipofilter 3000 fat collection canisters because they were not manufactured under Good Manufacturing Procedures, potentially preventing proper sterilization.

    Product
    Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1538-2012·2012-06-20

    Philips Healthcare Recalls Mobile X-ray Systems Due to Unintended Radiation

    Philips Healthcare is recalling 11 mobile X-ray systems because they may generate unintended radiation pulses when switched off or parked.

    Product
    Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2012·2012-06-20

    Aesculap Recalls Columbus Tibia Plateau Components Due to Specification Defects

    Aesculap Implant Systems is recalling eight Columbus Tibia Plateau components because they were found out of specification during internal quality inspection.

    Product
    Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2012·2012-06-20

    GE Proteus XR/a Radiographic System Recalled Due to Pinch Hazard

    General Electric is recalling 3,796 Proteus XR/a Radiographic Systems worldwide because an operator's finger was pinched between the fixed roller and the gliding tabletop.

    Product
    GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, WI. Model Number: 2259988. Product is indicated for use in generating radiographic images of human anatomy in all general-purpose diagnostic procedures. This device is not intended for mammographic…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1797-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action

    Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers nationwide distribution across 23 states.

    Product
    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1800-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action

    Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes. The recall covers syringes and kits distributed nationwide.

    Product
    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits

    Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary recall of VY Flush Heparin Lock Flush Syringes.

    Product
    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes and Dressing Change Kits

    Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.

    Product
    Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1794-2012·2012-06-20

    Plasma Surgical Recalls PlasmaJet Open Surgery Handpieces Due to Seal Failure

    Plasma Surgical Inc. is recalling 36 PlasmaJet Open Surgery Handpieces because a potential seal failure may cause a small drop of distilled water coolant to leak during use.

    Product
    PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1799-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action

    Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The recall covers products distributed nationwide.

    Product
    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes and Kits

    Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.

    Product
    Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1798-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action

    Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The syringes are used to maintain the patency of indwelling catheter lumens.

    Product
    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes and Kits

    Vygon is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.

    Product
    Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1801-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action

    Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits nationwide.

    Product
    Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide