Product Recalls in Indiana

Product recalls affecting Indiana — including food, drugs, consumer products, medical devices, and vehicles distributed to Indiana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,725 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,725 in last 12 months

Showing 98619880 of 29,228 recalls

Medical DeviceApril 21, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Centaur Syphilis Assay-SYP Kit Recalled by Siemens Healthcare Diagnostics,...

The Issue: Potential for the ADVIA Centaur Syphilis assay to carryover into other...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 21, 2021· Boston Scientific Corporation

Recalled Item: ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for...

The Issue: One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 20, 2021· Medivators, Inc.

Recalled Item: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in...

The Issue: The lot may have experienced an anomaly during the manufacturing process,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 20, 2021· Elekta, Inc.

Recalled Item: Elekta MOSAIC Oncology Information System versions: 2.62 Recalled by Elekta,...

The Issue: Malware attack

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 20, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: Multitom RAX with software version VF10 Recalled by Siemens Medical...

The Issue: Siemens identified two issues, In some cases, it is possible to perform an...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 20, 2021· Signature Orthopedics Pty Limited

Recalled Item: Logical cup liner - Product Usage: intended to replace a Recalled by...

The Issue: Product mislabeled, with the incorrect product inside the package.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 20, 2021· WillowWood Global Llc

Recalled Item: Alpha Interlock Suspension System Lanyard Body: An external prosthetic...

The Issue: the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 19, 2021· EHOB, Inc.

Recalled Item: Econocare Plus Waffle Overlay- Intended for use as a medical Recalled by...

The Issue: Product contamination-a trace amount of dried bodily fluids may expose...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 19, 2021· GE Healthcare, LLC

Recalled Item: Case Cardiac Assessment System for Exercise Testing and CardioSoft...

The Issue: If a certain sequence of events occur, the pdf test report that belongs to...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 19, 2021· GE Healthcare, LLC

Recalled Item: GE Healthcare Innova IGS 3 (GTIN 00840682147378) Recalled by GE Healthcare,...

The Issue: The IGS system can experience a single vertical line defect where the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 19, 2021· CHANGE HEALTHCARE CANADA COMPANY

Recalled Item: Change Healthcare Enterprise Viewer - Product Usage: intended to be Recalled...

The Issue: A software defect was identified where the Image Styles defined by...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Luminex Corporation

Recalled Item: ARIES HSV 1&2 Assay Recalled by Luminex Corporation Due to Impacted lot may...

The Issue: Impacted lot may leak inside the ARIES instrument.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Aesculap Implant Systems LLC

Recalled Item: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU Recalled by...

The Issue: Malfuncton-Implant did not deploy successfully may necessitate the need for...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Aesculap Implant Systems LLC

Recalled Item: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13...

The Issue: Malfuncton-Implant did not deploy successfully may necessitate the need for...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· BioFire Diagnostics, LLC

Recalled Item: FilmArray Pneumonia Panel (Penumo) Recalled by BioFire Diagnostics, LLC Due...

The Issue: Elevated rates of false positive/false negative and control failures while...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Hardy Diagnostics

Recalled Item: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer....

The Issue: Instruments were assembled and serviced using a defective lot of tubing,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Draeger Medical, Inc.

Recalled Item: Critical Care Ventilator Recalled by Draeger Medical, Inc. Due to Three...

The Issue: Three separate and unrelated problems attributed to the software used in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Draeger Medical, Inc.

Recalled Item: Critical Care Ventilator Recalled by Draeger Medical, Inc. Due to Three...

The Issue: Three separate and unrelated problems attributed to the software used in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Draeger Medical, Inc.

Recalled Item: Critical Care Ventilator Recalled by Draeger Medical, Inc. Due to Three...

The Issue: Three separate and unrelated problems attributed to the software used in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceApril 16, 2021· Draeger Medical, Inc.

Recalled Item: Critical Care Ventilator Recalled by Draeger Medical, Inc. Due to Three...

The Issue: Three separate and unrelated problems attributed to the software used in the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing