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. 2,666 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,666 in last 12 months

Showing 1128111300 of 29,286 recalls

Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter Recalled by Vascular Solutions, Inc. Due to The...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to...

The Issue: The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter. Recalled by Vascular Solutions, Inc. Due to...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter. Recalled by Vascular Solutions, Inc. Due to...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: BELLATEK TITANIUM ABUTMENT 4.1MM Number: EDAT4 Recalled by Biomet 3i, LLC...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Numbers:...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Pediatric Nephrostomy Stent Set Recalled by Cook Inc. Due to The indwell...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Cook Inc.

Recalled Item: Percutaneous Neonatal Pigtail Nephrostomy Set Recalled by Cook Inc. Due to...

The Issue: The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Brainlab AG

Recalled Item: Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for...

The Issue: Brainlab Ultrasound Navigation Software does not support the modification of...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Number: IEDAT5 Recalled by Biomet...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 4.1MM Number: IEDAN4 Recalled by Biomet 3i,...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Number: IEDAT4 Recalled by Biomet...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Number: IEDAT6 Recalled by Biomet...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Ultradent Products, Inc.

Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage: Recalled by...

The Issue: Due to a potential manufacturing issue (cross contamination), composite is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Number: IEDAN5 Recalled by Biomet 3i,...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope...

The Issue: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k)...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Greiner Bio-One North America, Inc.

Recalled Item: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator Recalled by Greiner...

The Issue: Blood collection tubes experienced an issue with separation and clotting

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens epoc BGEM Test Card-In vitro diagnostic device for the Recalled by...

The Issue: Sporadically inconsistent discrepant (low bias) glucose results on card lot...

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

Class II — Potential Health HazardOngoing