Product Recalls in Michigan

Product recalls affecting Michigan — including food, drugs, consumer products, medical devices, and vehicles distributed to Michigan. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,563 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,563 in last 12 months

Showing 2406124080 of 53,342 recalls

Medical DeviceMarch 7, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica Sample Handler Prime Recalled by Siemens Healthcare Diagnostics,...

The Issue: There were multiple issues identified in the system software which required...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1300 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: There were multiple issues identified in the system software which required...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· BioFire Diagnostics, LLC

Recalled Item: FilmArray BCID Panel Recalled by BioFire Diagnostics, LLC Due to Potential...

The Issue: Increased risk of false positive Enterobacteriaceae and Escherichia coli...

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

Class II — Potential Health HazardOngoing
DrugMarch 6, 2019· American Health Packaging

Recalled Item: Valsartan Tablets USP 160 mg Recalled by American Health Packaging Due to...

The Issue: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 6, 2019· Dr. Reddy's Laboratories, Inc.

Recalled Item: Docetaxel Injection USP Recalled by Dr. Reddy's Laboratories, Inc. Due to...

The Issue: Defective Container: complaint for seal and cap vial issues that could lead...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceMarch 6, 2019· BioFire Diagnostics, LLC

Recalled Item: FilmArray Gastrointestinal (GI) Panel Recalled by BioFire Diagnostics, LLC...

The Issue: Elevated rates of false positive results for Campylobacter and...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 6, 2019· Topcon Medical Systems, Inc.

Recalled Item: IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a Recalled by Topcon...

The Issue: When a patient is selected in the patient data and another patient is...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 6, 2019· PROCEPT BIOROBOTICS CORPORATION

Recalled Item: AquaBeam Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to...

The Issue: Certain lots may develop an internal leak due to a micro-crack in a specific...

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

Class II — Potential Health HazardOngoing
DrugMarch 5, 2019· USA LESS Inc.

Recalled Item: LEOPARD Miracle Honey packaged in a wooden box Recalled by USA LESS Inc. Due...

The Issue: Marketed Without An Approved NDA/ANDA: product tainted with undeclared...

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

Class I — Serious Health HazardOngoing
Refund
DrugMarch 5, 2019· AVKARE Inc.

Recalled Item: Losartan Potassium and Hydrochlorothiazide Tablets Recalled by AVKARE Inc....

The Issue: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA)...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 5, 2019· AVKARE Inc.

Recalled Item: Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes...

The Issue: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA)...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 5, 2019· AVKARE Inc.

Recalled Item: Losartan Potassium and Hydrochlorothiazide Tablets Recalled by AVKARE Inc....

The Issue: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA)...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceMarch 5, 2019· Fenwal Inc

Recalled Item: Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled...

The Issue: Based on internal investigations, Fresenius Kabi has identified a...

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

Class II — Potential Health HazardOngoing
DrugMarch 4, 2019· Petra Hygienic Systems Int Ltd

Recalled Item: ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan) Recalled by Petra...

The Issue: Does Not Meet Monograph: product contains, triclosan, an ingredient that can...

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

Class III — Low RiskOngoing
Refund
Medical DeviceMarch 3, 2019· Viewray, Inc.

Recalled Item: MRIdian Linac Radiation Therapy System Model 10000 and 20000 Recalled by...

The Issue: Issue with transferring treatment regiment from one system to another....

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

Class II — Potential Health HazardOngoing
DrugMarch 1, 2019· American Health Packaging

Recalled Item: Aspirin and Extended-release Dipyridamole Capsules Recalled by American...

The Issue: Failed Impurities/Degradation Specifications; out of specification result...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 1, 2019· AVKARE Inc.

Recalled Item: Oxybutynin Chloride Extended-Release Tablets USP 10 mg Recalled by AVKARE...

The Issue: Failed Dissolution Specifications

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

Class III — Low RiskOngoing
Refund
DrugMarch 1, 2019· Apotex Inc.

Recalled Item: Drospirenone and Ethinyl Estradiol Tablets Recalled by Apotex Inc. Due to...

The Issue: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceMarch 1, 2019· Thoratec Corp.

Recalled Item: Thoratec HeartMate 3 Coring Tool Recalled by Thoratec Corp. Due to Small...

The Issue: Small black plastic particle was observed in the left ventricle during...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Integra Limited

Recalled Item: Integra bioBLOCK Resorbable subtaler Implant Recalled by Integra Limited Due...

The Issue: Temperature indicator may have changed color to dark gray or black prior to...

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

Class II — Potential Health HazardOngoing