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. 1,077 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
1,077 in last 12 months

Showing 15061–15080 of 29,286 recalls

Medical DeviceDecember 7, 2018· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK STEM with Microporous Surface MP Reconstruction Prosthesis Recalled by...

The Issue: The reaming guide and the guide rod can't be screwed into the intended...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 7, 2018· Spectranetics Corporation

Recalled Item: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter Recalled by...

The Issue: The incorrect outer carton box was used for the product.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Medtronic Navigation, Inc.

Recalled Item: Medtronic Adapter Percutaneous Pin Recalled by Medtronic Navigation, Inc....

The Issue: Under certain circumstances, the percutaneous pin adapter used with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Carl Zeiss Meditec, Inc.

Recalled Item: VisuMax Software Version 2.10.13 with activated Software-Module ReLEx...

The Issue: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Vygon U.S.A.

Recalled Item: Vygon DUALSTOP Red Cap used for intravascular lines Product Code: Recalled...

The Issue: DualStop Caps defect causing leaks in affected product

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Vygon U.S.A.

Recalled Item: Vyon DUALSTOP White Cap used for intravascular lines Product Code: Recalled...

The Issue: DualStop Caps defect causing leaks in affected product

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Bard Medical Division

Recalled Item: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature...

The Issue: Some SureStep" Foley Tray Systems with product catalog number A319418AM and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 6, 2018· Hologic, Inc.

Recalled Item: I-View¿ Contrast Enhanced Digital Mammography Recalled by Hologic, Inc. Due...

The Issue: Calibration issue not possible to visualize contrast uptake in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: UniCel DxC 660i Recalled by Beckman Coulter Inc. Due to When racks are...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Beckman Coulter Inc.

Recalled Item: The UniCel DxI 600 and 800 Access Immunoassay Systems Recalled by Beckman...

The Issue: When racks are front-loaded onto the sample presentation unit while samples...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Exactech, Inc.

Recalled Item: Equinoxe Preserve Humeral Stem Recalled by Exactech, Inc. Due to Possibility...

The Issue: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 5, 2018· Medela Inc

Recalled Item: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model:...

The Issue: The sterility may be compromised due to a potential breach in the packaging,...

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

Class III — Low RiskOngoing
Medical DeviceDecember 5, 2018· Sage Products Inc

Recalled Item: Toothete Oral Care Sodium Bicarbonate Mouthpaste Recalled by Sage Products...

The Issue: A voluntary recall of a lot (67924) of Independent Care System due to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: BiMobile UHMWPE Liner: ID-28mm/OD-54mm Recalled by Waldemar Link GmbH & Co....

The Issue: The internal labeling included with these implants may include incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Agfa-Gevaert, N.V.

Recalled Item: DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 Recalled by...

The Issue: After an upgrade of the software of the Overhead Tube Crane, there were...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: BiMobile UHMWPE Liner: ID-28mm/OD-50mm Recalled by Waldemar Link GmbH & Co....

The Issue: The internal labeling included with these implants may include incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 4, 2018· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Triton Sponge System (Software) Recalled by Stryker Instruments Div. of...

The Issue: Gauss Surgical is updating the Instructions for Use (IFU) for our Triton...

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

Class III — Low RiskOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Control 3 Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Calibrator Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 3, 2018· Randox Laboratories Ltd.

Recalled Item: Fructosamine Control 1 Recalled by Randox Laboratories Ltd. Due to The firm...

The Issue: The firm is conducting a Device Modification for Fructosamine Calibrator,...

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

Class II — Potential Health HazardOngoing