State

Indiana product recalls

73,809 recalls have nationwide distribution and so reach Indiana. 9,598 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,598
Critical: 1,908
Severe: 2,536
Most recent: 2026-11-04

Of the 9,598 recalls naming Indiana we have scored against our rubric, 1,908 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,536 (26%) are Severe.

Which agencies issued them

These figures cover only the 9,598 recalls whose distribution notice names Indiana specifically. The 73,809 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

40526–40550 of 83407

ModerateFDA (Drugs)·D-0119-2019·2018-11-07
Sprayology Recalls Stress Relief Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 3,896 bottles of Stress Relief Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0006-1 and Tester NDC 61096-1006-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0327-2019·2018-11-07
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 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 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 (Devices)·Z-0319-2019·2018-11-07
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 20mm, Catalog Number: ZIB5-125-5.0-20 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-0328-2019·2018-11-07
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: ZIB6-125-14.0-30 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-0353-2019·2018-11-07
Beckman Coulter Recalls iPAW Software Due to Barcode Labeling Errors
Beckman Coulter is recalling iPAW software versions 4.2 and 4.2.1 because a specific barcode printing feature may generate incorrect IDs for tube labels.
Product
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0110-2019·2018-11-07
Sprayology Recalls Bone Builder Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling Bone Builder Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0105-2019·2018-11-07
Sprayology Recalls Rejuvenation Plus Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 1,558 bottles of Rejuvenation Plus Homeopathic Oral Spray due to manufacturing conditions that could result in possible microbial contamination.
Product
Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2019·2018-11-07
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 20mm, Catalog Number: ZIB5-125-4.0-20 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-0345-2019·2018-11-07
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 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 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-0294-2019·2018-11-07
RayStation Software Recalled for Unsupported Robust Optimization Feature
RaySearch Laboratories AB is recalling RayStation software versions 4.5 through 7 because robust optimization for specific plans is not supported.
Product
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0322-2019·2018-11-07
Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions
Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.
Product
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 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-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 (Drugs)·D-0128-2019·2018-11-07
Boehringer Ingelheim Recalls Catapres Tablets Due to Dissolution Failures
Boehringer Ingelheim is recalling specific bottles of Catapres tablets because routine stability testing revealed they failed to meet dissolution specifications.
Product
Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01
Category
Drug
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 (Drugs)·D-0109-2019·2018-11-07
Sprayology Recalls MenoPower Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling MenoPower Homeopathic Oral Spray because it was manufactured under conditions that could result in possible microbial contamination.
Product
MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0014-1 and Tester NDC 61096-1014
Category
Drug
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