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. 2,565 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,565 in last 12 months

Showing 2304123060 of 53,528 recalls

Medical DeviceMay 31, 2019· Infinium Medical, Inc

Recalled Item: CLEO Patient Monitor /Tranquility VS Patient Monitor Recalled by Infinium...

The Issue: The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the...

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

Class II — Potential Health HazardOngoing
FoodMay 31, 2019· Izzio Artisan Bakery, LLC

Recalled Item: Izzio Artisan Bakery 100% Rye Bread Recalled by Izzio Artisan Bakery, LLC...

The Issue: 100% Rye Bread may contain undeclared wheat.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceMay 30, 2019· Boston Scientific Neuromodulation Corporation

Recalled Item: Nitinol Thermocouple Electrode Recalled by Boston Scientific Neuromodulation...

The Issue: The firm initiated a voluntary correction of certain Cosman TCN Electrodes...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Boston Scientific Neuromodulation Corporation

Recalled Item: Nitinol Thermocouple Electrode Recalled by Boston Scientific Neuromodulation...

The Issue: The firm initiated a voluntary correction of certain Cosman TCN Electrodes...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Boston Scientific Neuromodulation Corporation

Recalled Item: Nitinol Thermocouple Electrode Recalled by Boston Scientific Neuromodulation...

The Issue: The firm initiated a voluntary correction of certain Cosman TCN Electrodes...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Boston Scientific Neuromodulation Corporation

Recalled Item: Nitinol Thermocouple Electrode Recalled by Boston Scientific Neuromodulation...

The Issue: The firm initiated a voluntary correction of certain Cosman TCN Electrodes...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Boston Scientific Neuromodulation Corporation

Recalled Item: Nitinol Thermocouple Electrode Recalled by Boston Scientific Neuromodulation...

The Issue: The firm initiated a voluntary correction of certain Cosman TCN Electrodes...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Becton Dickinson & Company

Recalled Item: BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number:...

The Issue: Lot has been confirmed to have no additive within the tube. Sample processed...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 30, 2019· Medline Industries, Inc.

Recalled Item: Anti-fog solution packaged in a Tyvek peel pouch and it Recalled by Medline...

The Issue: The Anti-Fog Solution may not defog properly due to a degradation in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 29, 2019· Siemens Healthcare Diagnostics Inc

Recalled Item: Stratus CS Acute Care cTNI TestPak Recalled by Siemens Healthcare...

The Issue: Potential for increased rate of false positive results and/or increased rate...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 29, 2019· Fresenius Medical Care Renal Therapies Group, LLC

Recalled Item: Liberty Cycler Cassettes (a disposable cassette that is intended to Recalled...

The Issue: Additional Instructions: step-by step handling and inserting the cassette...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 29, 2019· AtriCure, Inc.

Recalled Item: EPi-Sense Guided Coagulation System with Visitrax Recalled by AtriCure, Inc....

The Issue: The sterile package seal for the Epi-Sense Guided Coagulation System may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Zimmer Biomet, Inc.

Recalled Item: DVR Crosslock ePAK Screw Driver Recalled by Zimmer Biomet, Inc. Due to There...

The Issue: There is a potential for weak seals of the sterile packaging.

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model:...

The Issue: Potential that the coating of the light head forks on the VOLISTA Surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model:...

The Issue: Potential that the coating of the light head forks on the VOLISTA Surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Zimmer Biomet, Inc.

Recalled Item: K-Wire Trochar Tip Recalled by Zimmer Biomet, Inc. Due to There is a...

The Issue: There is a potential for weak seals of the sterile packaging.

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM go.All (Model #11061630) Recalled by Siemens Medical Solutions USA,...

The Issue: The potential sporadic performance problems may result in scanning workflow...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM go.Top (Model #1161640) Recalled by Siemens Medical Solutions USA,...

The Issue: The potential sporadic performance problems may result in scanning workflow...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· GN Otometrics

Recalled Item: The ICS CHARTR EP 200 Recalled by GN Otometrics Due to There is a risk to...

The Issue: There is a risk to the healthcare professional or patient of exposure to...

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

Class II — Potential Health HazardOngoing
Medical DeviceMay 28, 2019· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM go.Now (Model #11061620) Recalled by Siemens Medical Solutions USA,...

The Issue: The potential sporadic performance problems may result in scanning workflow...

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

Class II — Potential Health HazardOngoing