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.

Filters

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

37351–37375 of 40449

  • ModerateFDA (Devices)·Z-0074-2014·2013-11-06

    Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen Femoral Components because the packaging bags adhere to the device surfaces. The recall covers 11,694 units distributed worldwide.

    Product
    NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0116-2014·2013-11-06

    GE Centricity PACS Workstation Recalled for Workflow Interruption Issues

    GE Healthcare is recalling 623 Centricity PACS Workstations due to software workflow interruptions that may prevent exams from closing correctly in the system.

    Product
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0090-2014·2013-11-06

    Carestream DRX Revolution Mobile X-Ray System Recalled for Image Artifacts

    Carestream Health is recalling 23 DRX Revolution Mobile X-Ray Systems because a software update without detector calibration can cause image artifacts.

    Product
    DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0068-2014·2013-11-06

    Zimmer Multipolar Bipolar Cup Metal Shell Recall Due to Packaging Adhesion

    Zimmer, Inc. is recalling Multipolar Bipolar Cup Metal Shell implants because the packaging bag adheres to the device surface.

    Product
    Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2014·2013-11-06

    HemoCue Hb 201 Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling HemoCue Hb 201 Microcuvettes due to a production-related issue causing punctured single-pack pouches.

    Product
    HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-0093-2014·2013-11-06

    DePuy Spine Pipeline LS Dilator Recall for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 118 Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0071-2014·2013-11-06

    Zimmer Recalls Metasul Head Implants Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling Metasul Head implants because the low-density polyethylene packaging bags adhere to the device surfaces.

    Product
    Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2014·2013-11-06

    Xoran MiniCAT CT Scanner Recalled for Dose Rate Non-Compliance

    Xoran Technologies is recalling 320 MiniCAT CT Scanners because they failed to meet specifications for dose rate. The devices may operate at dose rates higher or lower than required.

    Product
    Xoran MiniCAT CT Scanner
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0072-2014·2013-11-06

    Zimmer Recalls CoCr Hip Replacement Heads Due to Packaging Adhesion

    Zimmer, Inc. is recalling CoCr heads used in total hip replacements because the packaging bags adhere to the device surfaces.

    Product
    CoCr Head (Not distributed in the United States) Used in total hip replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0094-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0075-2014·2013-11-06

    Zimmer Natural-Knee Flex Femoral Component Packaging Adhesion Recall

    Zimmer, Inc. is recalling Natural-Knee Flex Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    Product
    Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0097-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Holding Clips for Uncleared Use

    DePuy Spine is recalling 198 Pipeline LS Holding Clips because they were used for neuromonitoring, a function for which the device is not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0078-2014·2013-11-06

    Zimmer Natural-Knee II Femoral Component Packaging Adhesion Recall

    Zimmer, Inc. is recalling Natural-Knee II Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    Product
    Natural-Knee¿ II Femoral Component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2014·2013-11-06

    Intuitive Surgical da Vinci Single Site Instruments Recalled for Missing Manual Revisions

    Intuitive Surgical is recalling specific da Vinci Single Site instruments because they were shipped without the correct user manual revision, which contains necessary instructions, warnings, and precautions.

    Product
    Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0083-2014·2013-11-06

    Medtronic Recalls Thoracic Stent Grafts Due to Flushing Difficulty

    Medtronic Vascular is recalling Valiant and Talent Thoracic Stent Grafts with Captivia Delivery Systems because the graft cover is difficult to flush during preparation.

    Product
    Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0100-2014·2013-11-06

    Sysmex pocH-100i Automated Hematology Analyzer Recalled for Data Omission

    Sysmex America Inc is recalling 193 pocH-100i Automated Hematology Analyzers because the thermal printer may omit digits or decimal points in printed results.

    Product
    pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0076-2014·2013-11-06

    Zimmer Unicompartmental Knee Femoral Component Packaging Recall

    Zimmer, Inc. is recalling knee implant components because the packaging bags adhere to the device surfaces.

    Product
    Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0099-2014·2013-11-06

    Baxter CLEARLINK Extension Set Recalled for Packaging Pinholes

    Baxter Healthcare is voluntarily recalling 3,200 units of CLEARLINK Extension Sets due to potential pinholes in the packaging that could breach the sterile barrier.

    Product
    Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0081-2014·2013-11-06

    Cordis Recalls Optease Vena Cava Filter Due to Printing Error

    Cordis is recalling 29,395 Optease Vena Cava Filters because a printing error on one unit caused it to be implanted upside down, requiring an additional procedure.

    Product
    Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0098-2014·2013-11-06

    Small Bone Innovations Recalls Radial and Ulnar Stem Implants

    Small Bone Innovations is recalling 2,036 radial and ulnar stem implants due to a risk of sterile packaging breach.

    Product
    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0086-2014·2013-11-06

    HemoCue Urine Albumin Microcuvettes Recalled for Punctured Packaging

    HemoCue AB is recalling Urine Albumin Microcuvettes due to a production issue causing punctured single-pack pouches.

    Product
    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2014·2013-11-06

    Philips Recalls BrightView XCT Gamma Cameras Due to Latch Failure

    Philips is recalling 371 BrightView XCT gamma cameras because the Flat Panel Detector may not remain securely latched in the stowed position.

    Product
    BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging…
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-0096-2014·2013-11-06

    DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use

    DePuy Spine is recalling 100 units of Pipeline LS Dilators because they were used for neuromonitoring, a function for which the device is not FDA cleared.

    Product
    PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide