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. 2,532 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,532 in last 12 months

Showing 2236122380 of 29,286 recalls

Medical DeviceSeptember 22, 2015· Sentinel CH SpA

Recalled Item: Sentinel MULTIGENT Ammonia Ultra Reagent Recalled by Sentinel CH SpA Due to...

The Issue: Results for ammonia are below the linear range of the assay for samples that...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2015· Merge Healthcare, Inc.

Recalled Item: Merge Cardio software. Product Usage: Merge Cardio is a system Recalled by...

The Issue: Users can merge a device import file with an image study that already has a...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2015· Merge Healthcare, Inc.

Recalled Item: Merge Cardio software with Issuer of Patient ID (IPID). The Recalled by...

The Issue: For sites using the Issuer of Patient ID (IPID), the system will display the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Biomet 3i, LLC

Recalled Item: BIOMET 3i Recalled by Biomet 3i, LLC Due to Inadequate biocompatibility testing.

The Issue: Inadequate biocompatibility testing.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Biomet 3i, LLC

Recalled Item: BIOMET 3i Recalled by Biomet 3i, LLC Due to Inadequate biocompatibility testing.

The Issue: Inadequate biocompatibility testing.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Biomet 3i, LLC

Recalled Item: BIOMET 3i Recalled by Biomet 3i, LLC Due to Inadequate biocompatibility testing.

The Issue: Inadequate biocompatibility testing.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Valeant Pharmacueticals International

Recalled Item: Valeant Pharmaceuticals North America Recalled by Valeant Pharmacueticals...

The Issue: The Serial I.D. Label and some information in the Operation Manual for the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Biocompatibles U.K., Ltd.

Recalled Item: TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is...

The Issue: One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Biomet 3i, LLC

Recalled Item: BIOMET 3i Recalled by Biomet 3i, LLC Due to Inadequate biocompatibility testing.

The Issue: Inadequate biocompatibility testing.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Synthes (USA) Products LLC

Recalled Item: Synthes Screw Inserter Recalled by Synthes (USA) Products LLC Due to Certain...

The Issue: Certain lots of the Screw Inserter may be etched with incorrect graphics....

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Brainlab AG

Recalled Item: Digital Lightbox Recalled by Brainlab AG Due to Potentially incorrectly...

The Issue: Potentially incorrectly displayed objects when actively deselecting a fused...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2015· Stryker Howmedica Osteonics Corp.

Recalled Item: Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile....

The Issue: Stryker Orthopaedics has received two customer complaints regarding Duracon...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 18, 2015· Arrow International Inc

Recalled Item: 4FR Single Lumen Pressure Injectable PICC Recalled by Arrow International...

The Issue: Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2015· LifeHealth, LLC

Recalled Item: CC cartridges for IRMA TRUPOINT Blood Gas Analyzer Recalled by LifeHealth,...

The Issue: May report values outside the published performance specifications for pH....

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2015· GE Healthcare

Recalled Item: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is Recalled by...

The Issue: Images may be missing when a system parameter MapRoute is set to a value...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2015· LifeHealth, LLC

Recalled Item: BG cartridges for IRMA TRUPOINT Blood Gas Analyzer Recalled by LifeHealth,...

The Issue: May report values outside the published performance specifications for pH....

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2015· Medtronic Inc. Cardiac Rhythm Disease Management

Recalled Item: Medtronic Medical Device Identification Card for SureScan pacemaker...

The Issue: Some Medical Device Identification Cards provided to SureScan pacemaker...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2015· Elekta, Inc.

Recalled Item: Monaco Radiation Treatment Planning System. Used to make treatment plans...

The Issue: Dose and MU are incorrect when CT images are viewed from the head, and, when...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2015· Medtronic Navigation, Inc.

Recalled Item: P/N: 9734856 Recalled by Medtronic Navigation, Inc. Due to Specific use...

The Issue: Specific use conditions can increase the possibility of a screwdriver tip...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core Computed Tomography X-ray systems. Intended to produce...

The Issue: The firm discovered Ring/Dot artifact due to X-ray measurement error.

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

Class II — Potential Health HazardOngoing