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 deaths or serious injuries are reported, 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

12676–12700 of 13837

  • HighFDA (Devices)·Z-0237-2022·2021-11-24

    Hip implant stem missing surface treatment affecting seven units

    OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.

    Product
    OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0255-2022·2021-11-24

    REGARD Ultrasound Trays Recalled for Out-of-Specification Swabstick Component

    ROi CPS LLC has recalled REGARD Ultrasound Trays because they contain out-of-specification Povidone-Iodine swabstick components. The 240 affected trays were distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ultrasound Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0226-2022·2021-11-24

    Sensis Diagnostic System UI Freeze Risk Without Regular System Reboots

    Siemens' Sensis diagnostic systems may experience partial UI freezing and fail to update vital signs display if not rebooted at least every 7 days per manufacturer instructions.

    Product
    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology stud
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2022·2021-11-24

    SMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement

    Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.

    Product
    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0227-2022·2021-11-24

    Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle

    Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.

    Product
    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2022·2021-11-24

    Ilizarov Wire Tensioner Recalled Due to Manufacturing Defect

    Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners (Model 71070341) due to an internal washer made of incorrect material. The washer could wear and break during autoclave sterilization, causing the tensioner to malfunction.

    Product
    Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0263-2022·2021-11-24

    FDA Class II Quantum 2000 Electrosurgical Generators Voluntary Recall

    CooperSurgical is voluntarily recalling 154 Quantum 2000 Electrosurgical Generators under FDA Class II classification. The specific reason for recall is not documented in available source information.

    Product
    Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2022·2021-11-24

    Reproductive Medical Device Recalled for Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze, a medical device used in assisted reproductive procedures, due to kit components being labeled with incorrect expiration dates.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0249-2022·2021-11-24

    Vitrification Freeze Kit Recalled Due to Incorrect Expiration Date Labeling

    Fujifilm Irvine Scientific is recalling Vit Kit-Freeze due to incorrect expiration date labeling on a component. The incorrect label could lead to use of degraded solutions in assisted reproductive procedures.

    Product
    Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. This kit is designed for use with CryoTip (Catalog #40709), and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2022·2021-11-24

    REGARD Vitrectomy Tray Recalled for Out-of-Specification Antiseptic Component

    ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because the povidone-iodine swab component was manufactured out of specifications. Distribution was limited to Florida, Louisiana, and Missouri.

    Product
    REGARD Vitrectomy Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0247-2022·2021-11-24

    VITROS Immunodiagnostic Anti-HBc Controls Recalled Due to Incorrect Booklet Information

    Ortho-Clinical Diagnostics recalled 191 units of VITROS Anti-HBc IgM Controls (Lot 1690) because the Controls Values booklet contained incorrect product information. Although patient test result accuracy is not affected, there is potential for delayed quality control troubleshooting.

    Product
    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0183-2022·2021-11-17

    Ellume COVID-19 Home Test Recalled for Higher Rate of False Positives

    Ellume recalled approximately 427,994 COVID-19 home test kits due to a higher rate of false positive results. The affected kits were distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, and Washington.

    Product
    Ellume COVID-19 Home Test
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0210-2022·2021-11-17

    Covidien Emprint Ablation Catheter temperature monitoring defect

    Covidien is recalling the Emprint Ablation Catheter due to a defect in temperature monitoring circuitry. If the cooling system fails during use, the device tip could overheat, causing tissue burns, unintended ablation, and allergic reactions.

    Product
    Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0215-2022·2021-11-17

    Hemodialysis Delivery System Software May Use Incorrect Treatment Parameters

    Baxter's Hemodialysis Delivery System may incorrectly revert to old prescription values when operators change prescriptions after filter changes, potentially resulting in incorrect treatment parameters.

    Product
    Hemodialysis Delivery System, Software Version 2.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2022·2021-11-17

    Philips Azurion X-Ray Systems may lock up during simultaneous button presses

    Philips Azurion Interventional X-Ray Systems (software 2.1.x) may experience imaging lock-up when operators simultaneously press both the APC and Float Tabletop buttons.

    Product
    Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2022·2021-11-17

    McKesson Safety Blood Collection Needles Recalled for Safety Mechanism Defect

    McKesson PREVENT HT Safety Blood Collection Needles are being recalled due to potential difficulty in activating the safety mechanism. The recall affects needles distributed nationwide, including specific lot numbers with expiration dates through May 2025.

    Product
    McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2022·2021-11-17

    McKesson Safety Blood Collection Needles Recalled Over Safety Mechanism Activation Risk

    Nationwide recall of McKesson PREVENT HT Safety Blood Collection Needles (22G 1 1/4 inch) due to potential difficulty activating the safety mechanism. The protective feature may fail to engage properly during use.

    Product
    McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2022·2021-11-17

    McKesson PREVENT HT Blood Collection Needle Safety Mechanism Activation Issue

    McKesson PREVENT HT blood collection needles with specific lot numbers may have difficulty activating their safety mechanism. Healthcare facilities should contact the manufacturer for replacement guidance.

    Product
    McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2022·2021-11-17

    McKesson PREVENT HT Winged Blood Collection Needles Recall for Safety Mechanism Difficulty

    McKesson PREVENT HT Safety Winged Blood Collection Needles may have difficulty activating their safety mechanism. The recall affects units distributed nationwide.

    Product
    McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2022·2021-11-17

    Photopheresis Kit Recalled Due to Incomplete Testing Before Release

    Therakos is recalling 15 photopheresis kits because they were released before testing was completed. If used, a drive tube leak could cause illness or injury.

    Product
    THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0208-2022·2021-11-17

    Safety Blood Collection Needle Recalled for Safety Mechanism Activation Issues

    Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.

    Product
    HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2022·2021-11-17

    Safety Blood Collection Needles Recalled Due to Safety Mechanism Activation Difficulty

    Henry Schein safety blood collection needles may have difficulty activating their safety mechanism, potentially increasing needlestick injury risk. Affected lots were distributed nationwide with expiration dates through late 2025.

    Product
    HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0211-2022·2021-11-17

    QuikClot Combat Gauze Recalled for Potential Sterile Packaging Seal Failure

    Z-Medica is recalling 2400 units of QuikClot Combat Gauze due to potential packaging seal failures that could compromise sterile barrier integrity. Affected lot 12645 was distributed nationwide.

    Product
    QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2022·2021-11-17

    T4 EIA Diagnostic Kit Recall Due to Shelf-Life Quality Standards Failure

    BioCheck, Inc. is recalling 314 T4 EIA Kit units due to failed shelf-life standards that resulted in failed quality control tests. The kits were distributed to five U.S. states and three overseas countries.

    Product
    T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
    Category
    Medical Device
    Distribution
    5 states