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

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

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

23701–23725 of 40175

  • HighFDA (Devices)·Z-1881-2018·2018-05-23

    Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1746-2018·2018-05-23

    Siemens Recalls CT Scanner Software for Radiation Risk

    Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1833-2018·2018-05-23

    Medtronic Endo GIA Universal Stapler Kits Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal stapler kits because a missing sled component may prevent staple formation, risking bleeding or leakage.

    Product
    BOX KIT00714 KIT SLEEVE Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1745-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens Medical Solutions is recalling 1,385 SOMATOM Definition AS CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1747-2018·2018-05-23

    Siemens CT Scanners Recalled for Potential Unnecessary Radiation Exposure

    Siemens is recalling 238 SOMATOM Definition Flash CT scanners due to a software issue in the CARE Dose4D algorithm that may cause unnecessary radiation exposure.

    Product
    SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1870-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2018·2018-05-23

    Southmedic Recalls Sterile Scalpels Labeled as Non-Sterile

    Southmedic, Inc. is recalling 3,300 sterile disposable scalpels because the product contains non-sterile items labeled as sterile.

    Product
    Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1867-2018·2018-05-23

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Inaccurate Pressure Readings

    Invivo is recalling 4,375 Xper Flex Cardio Physiomonitoring Systems because ventricular end-diastolic pressure readings may be inaccurate. The issue affects specific model numbers used in cardiac catheterization rooms.

    Product
    PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and 989803199561 (international only) The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2018·2018-05-23

    Siemens SOMATOM Force CT scanners recalled for radiation exposure risk

    Siemens is recalling 91 SOMATOM Force CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1803-2018·2018-05-23

    Bard Peripheral Vascular Seeker Crossing Support Catheter Recalled for Endotoxin Risk

    Bard Peripheral Vascular Inc is recalling 130 units of Seeker Crossing Support Catheters due to potential bacterial endotoxin on packaging hoops, posing a cross-contamination risk.

    Product
    BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Reagent Due to Potential Test Errors

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c reagents because the assay may produce erroneously high or low Hemoglobin A1c results.

    Product
    Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2018·2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling specific diagnostic X-ray systems due to a potential failure in the tube arm suspension that could cause the arm to descend uncontrollably.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1873-2018·2018-05-23

    Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes

    Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.

    Product
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1829-2018·2018-05-23

    Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component

    Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    (1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180) (2)BOX BOX1073180APPE1 APPENDIX KIT ZAMS (Item Code BOX1073180APPE1 APPENDIX KIT ZAMS) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2018·2018-05-23

    Visaris Diagnostic X-Ray System Recalled for Tube Arm Suspension Failure

    Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and injury.

    Product
    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1876-2018·2018-05-23

    Nipro Blood Tubing Set Recalled Due to Potential Heparin Line Occlusion

    Nipro Medical Corporation is recalling specific blood tubing sets used in hemodialysis because the heparin line may be occluded.

    Product
    Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1806-2018·2018-05-23

    Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments

    Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential raw material cracks that could compromise cleanliness.

    Product
    Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1811-2018·2018-05-23

    Tosoh Bioscience Recalls HbA1c Control Due to Erroneous Results

    Tosoh Bioscience Inc is recalling Tosoh ST AIA-PACK HbA1c Control because the product may generate erroneously elevated or decreased HbA1c patient results.

    Product
    Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2018·2018-05-23

    Tosoh HbA1c Calibrator Recalled for Potential Inaccurate Patient Results

    Tosoh Bioscience Inc is recalling HbA1c Calibrators because they may cause erroneous patient test results.

    Product
    Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2018·2018-05-23

    Ethicon 5mm Endopath Xcel Trocar Recalled for Lubrication Defect

    Ethicon Endo-Surgery Inc is recalling 5mm Endopath Xcel trocars due to insufficient lubrication, which may prolong surgery or introduce minute particles.

    Product
    5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2018·2018-05-23

    Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component

    Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may cause staple line failure, leading to bleeding or leakage.

    Product
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2018·2018-05-23

    Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks

    Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units due to potential cracks in the raw material that could compromise product cleanliness.

    Product
    Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2018·2018-05-23

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
    Category
    Medical Device
    Distribution
    Distributed nationwide