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. 2,560 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,560 in last 12 months

Showing 2416124180 of 53,528 recalls

Medical DeviceFebruary 25, 2019· Cook Medical Incorporated

Recalled Item: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Recalled by...

The Issue: Updates to the Instructions for Use.

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

Class III — Low RiskOngoing
Medical DeviceFebruary 25, 2019· Nidek, Inc.

Recalled Item: NIDEK Specular Microscope Recalled by Nidek, Inc. Due to The electromagnetic...

The Issue: The electromagnetic noise exceeded the upper limit of the Electromagnetic...

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

Class III — Low RiskOngoing
Medical DeviceFebruary 22, 2019· GE Healthcare, LLC

Recalled Item: Integrated ECG cable with 3-lead leadwires labeled as the following:...

The Issue: The Integrated ECG cable with 3-lead leadwires can short circuit during...

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

Class III — Low RiskOngoing
Medical DeviceFebruary 22, 2019· Luminex Molecular Diagnostics

Recalled Item: xTAG Gastrointestinal Pathogen Panel intended for the simultaneous...

The Issue: Reports have been received of lower MS2 MFI values when using the panel.

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

Class II — Potential Health HazardOngoing
DrugFebruary 22, 2019· Golean Detox US

Recalled Item: Golean DETOX capsules Recalled by Golean Detox US Due to Undeclared Sibutramine

The Issue: Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugFebruary 22, 2019· Akorn, Inc.

Recalled Item: Gentamicin Sulfate Ophthalmic Solution Recalled by Akorn, Inc. Due to Failed...

The Issue: Failed Impurities/Degradation Specifications: High Out-of-Specification...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugFebruary 22, 2019· Ascend Laboratories LLC

Recalled Item: Tamsulosin Hydrochloride Capsules Recalled by Ascend Laboratories LLC Due to...

The Issue: Failed Dissolution Specifications: High Out-of-Specification dissolution...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
FoodFebruary 22, 2019· Asia Food Distributor

Recalled Item: Nova Salted Biscuit The product comes in a 14.08 ounce Recalled by Asia Food...

The Issue: Product contains undeclared milk.

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

Class I — Serious Health HazardOngoing
Refund
DrugFebruary 21, 2019· Lannett Company Inc.

Recalled Item: Oxybutynin Chloride Recalled by Lannett Company Inc. Due to Failed...

The Issue: Failed Dissolution Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
Medical DeviceFebruary 21, 2019· ArthroCare Corporation

Recalled Item: Smith&Nephew SmartStitch PerfectPasser Connector Recalled by ArthroCare...

The Issue: The voluntary recall is being initiated due to a manufacturing error...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical ChemoLock Recalled by ICU Medical, Inc. Due to There is a...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap Recalled by...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical ChemoClave Vented Vial Spike Recalled by ICU Medical, Inc. Due to...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical ChemoClave Vented Vial Spike Recalled by ICU Medical, Inc. Due to...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap Recalled by ICU...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: icumedical ChemoLock Closed Vial Spike w/Skirt Recalled by ICU Medical, Inc....

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· ICU Medical, Inc.

Recalled Item: SetSource ChemoClave Vented Vial Spike Recalled by ICU Medical, Inc. Due to...

The Issue: There is a potential for certain lots of ChemoLock and ChemoClave Vial...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 21, 2019· Becton Dickinson & Co.

Recalled Item: BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD...

The Issue: BD Synapsys version 2.1 allowed the potential for a test order to be...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2019· Ortho-Clinical Diagnostics

Recalled Item: VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in...

The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 20, 2019· Ortho-Clinical Diagnostics

Recalled Item: VITROS¿ 5600 Integrated System V3.3.2 & below Product Code: Recalled by...

The Issue: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on...

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

Class II — Potential Health HazardOngoing