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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21926–21950 of 40299

  • ModerateFDA (Devices)·Z-0324-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2019·2018-11-07

    Fresenius Kabi Recalls Volumat MC Agilia Infusion Pumps for Software Upgrade

    Fresenius Kabi is recalling 7,082 Volumat MC Agilia Volumetric Infusion Pumps to install a mandatory software upgrade that prevents common software malfunctions.

    Product
    Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0344-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0342-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0330-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2019·2018-11-07

    Zilver 518 Biliary Stent recall issued due to incorrect instruction for use details

    The FDA is recalling the Zilver 518 Biliary Stent because its instruction for use details were incorrect, requiring updated deployment guidance.

    Product
    Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0341-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0340-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0343-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0284-2019·2018-11-07

    Acumedia Campylobacter Medium Recalled for Incorrect Expiration Date

    Acumedia Manufacturers is recalling 93 bottles of Campylobacter Blood Free Selective Medium due to incorrect expiration dates.

    Product
    Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0350-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0355-2019·2018-11-07

    Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0358-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.

    Product
    Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0349-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0368-2019·2018-11-07

    3M Fast Release Varnish Recalled for Unpleasant Flavor

    3M is recalling 73 units of Fast Release Varnish due to a manufacturing error that introduced extraneous material, causing an unpleasant flavor.

    Product
    3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0329-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0283-2019·2018-11-07

    Acumedia Palcam Agar Base Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers, Inc. is recalling 22 bottles of Palcam Agar Base because the expiration date on the label is incorrect.

    Product
    Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0337-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0321-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0359-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.

    Product
    Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0354-2019·2018-11-07

    Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors

    Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered tube labels.

    Product
    Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0188-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0187-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide