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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21901–21925 of 40339

  • ModerateFDA (Devices)·Z-0315-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

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

    Product
    Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 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-0338-2019·2018-11-07

    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 40mm, Catalog Number: ZIB6-80-12.0-40 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-0348-2019·2018-11-07

    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 40mm, Catalog Number: ZIB6-80-5.0-40 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
  • ModerateFDA (Devices)·Z-0351-2019·2018-11-07

    Cook Medical Recalls Zilver Biliary Stent Due to Incorrect Removal Instructions

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

    Product
    Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 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
  • ModerateFDA (Devices)·Z-0356-2019·2018-11-07

    Beckman Coulter iPAW 4.2 Software Recalled for Barcode Labeling Errors

    Beckman Coulter is recalling the iPAW 4.2 User Kit software because a specific manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckman Coulter Biomedical GmbH The iPAW 4.2 User Kit (PN B73489) includes the iPAW software application CD (version 4.2). This function is primarily used to copy an existing barcode ID to replace the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0352-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,384 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 80mm, Catalog Number: ZIB6-125-14.0-80 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-0346-2019·2018-11-07

    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 20mm, Catalog Number: ZIB6-80-5.0-20 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-0336-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

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

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 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
  • ModerateFDA (Devices)·Z-0339-2019·2018-11-07

    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 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 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-0282-2019·2018-11-07

    Arrow Multi-Lumen CVC Kit Recalled for Expired Product Documentation Error

    Arrow International Inc. is recalling 105 units of Arrow AGB + Multi-Lumen CVC Kits because shipping documentation listed an incorrect expiration date, though the product lidstock is correct.

    Product
    Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0320-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

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

    Product
    Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 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-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