State

Tennessee product recalls

73,809 recalls have nationwide distribution and so reach Tennessee. 7,860 additional recalls listed Tennessee specifically in their distribution scope.

What the numbers show

Total: 7,860
Critical: 1,324
Severe: 1,974
Most recent: 2026-11-04

Of the 7,860 recalls naming Tennessee we have scored against our rubric, 1,324 (17%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,974 (25%) are Severe.

Which agencies issued them

These figures cover only the 7,860 recalls whose distribution notice names Tennessee specifically. The 73,809 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

40226–40250 of 81669

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 (Drugs)·D-0116-2019·2018-11-07
Sprayology Recalls Party Relief Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 2,956 bottles of Party Relief Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0030-1 and Tester NDC 61096-1030-1
Category
Drug
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 (Drugs)·D-0115-2019·2018-11-07
Sprayology Recalls TravelEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,307 bottles of TravelEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in microbial contamination.
Product
TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879NDC 61096-0007-1. and Tester NDC 61096-1007-1
Category
Drug
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
ModerateFDA (Drugs)·D-0120-2019·2018-11-07
Sprayology Recalls PMS Support Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 647 bottles of PMS Support Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0031-1
Category
Drug
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