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. 2,520 recalls have been distributed to Michigan in the last 12 months.

53,342 total recalls
2,520 in last 12 months

Showing 2974129760 of 53,342 recalls

Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 119" Blood Set w/200 Micron Filter Recalled by ICU Medical, Inc. Due to Some...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 159" (404 cm) Y-Type Blood Set w/170 Micron Filter Recalled by ICU Medical,...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· ICU Medical, Inc.

Recalled Item: 88" (224 cm) Y-Type Blood Set w/200 Micron Filter Recalled by ICU Medical,...

The Issue: Some devices were labeled as Does not contain DEHP even though the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Oakworks Inc

Recalled Item: Foot Controls impacted for the following devices: OAKWORKS¿ Medical CFPM...

The Issue: The foot control used on the OAKWORKS¿ Inc., CFPM300, CFPM301, CFPM400,...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Tray Triple Lumen Polyurethane Catheter Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane...

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Set Triple Lumen Polyurethane Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Central Venous Catheter Tray Triple Lumen Polyurethane Recalled by Cook Inc....

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 31, 2017· Cook Inc.

Recalled Item: Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic...

The Issue: Central venous catheters may not fit over guide wire potentially causing...

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

Class II — Potential Health HazardOngoing
DrugJuly 28, 2017· PD-Rx Pharmaceuticals, Inc.

Recalled Item: Famotidine USP 20 mg Recalled by PD-Rx Pharmaceuticals, Inc. Due to Failed...

The Issue: Failed Tablet/Capsule Specification: out of specification for tablet weight.

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

Class II — Potential Health HazardOngoing
Refund
FoodJuly 28, 2017· SIlver HIlls Bakery

Recalled Item: Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns Recalled by...

The Issue: Undeclared eggs

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceJuly 28, 2017· Roche Diagnostics Corporation

Recalled Item: Cobas 8000 Modular Series system Recalled by Roche Diagnostics Corporation...

The Issue: A software failure may incorrectly set the system settings to "default"...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· Brainlab AG

Recalled Item: AIRO Mobile CT System Recalled by Brainlab AG Due to Risk of unintended...

The Issue: Risk of unintended motion while the AIRO system is in transport mode.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 28, 2017· NXTHERA

Recalled Item: Rezum System Recalled by NXTHERA Due to Needle Bond may not be able to...

The Issue: Needle Bond may not be able to withstand the tension force applied when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 2200TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Zimmer Surgical Inc

Recalled Item: A.T.S. 4000TS Tourniquet Systems Recalled by Zimmer Surgical Inc Due to...

The Issue: Updated on-device label and 3 pages of an updated Operator/Service Manual....

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Medtronic Navigation, Inc.

Recalled Item: VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559...

The Issue: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iFusion Recalled by Optovue, Inc. Due to FDA determined that a 510(k) is...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue with Normative Database Recalled by Optovue, Inc. Due to FDA determined...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 27, 2017· Optovue, Inc.

Recalled Item: iVue 500 with iScan Recalled by Optovue, Inc. Due to FDA determined that a...

The Issue: FDA determined that a 510(k) is needed for the Vault Mapping software (also...

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

Class II — Potential Health HazardOngoing