Product Recalls in Maine

Product recalls affecting Maine — including food, drugs, consumer products, medical devices, and vehicles distributed to Maine. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 1,035 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
1,035 in last 12 months

Showing 16541–16560 of 48,770 recalls

Medical DeviceNovember 19, 2020· Roche Molecular Systems, Inc.

Recalled Item: The cobas z 480 analyzer including dedicated software for IVD Recalled by...

The Issue: Dirty Lens May Cause Invalid or False Positive Results

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2020· Heartware, Inc.

Recalled Item: Medtronic HVAD Pump Implant Kits Recalled by Heartware, Inc. Due to Pumps...

The Issue: Pumps manufactured with impellers from a subset of lots from a single...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 19, 2020· Synthes (USA) Products LLC

Recalled Item: DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic Recalled by...

The Issue: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2020· Synthes (USA) Products LLC

Recalled Item: DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual...

The Issue: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2020· Synthes (USA) Products LLC

Recalled Item: DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual...

The Issue: RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in...

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

Class II — Potential Health HazardOngoing
DrugNovember 19, 2020· Areva Pharmaceuticals Inc

Recalled Item: Irinotecan Hydrochloride Injection Recalled by Areva Pharmaceuticals Inc Due...

The Issue: CGMP Deviations: based on a Warning Letter received by the manufacturer of...

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 18, 2020· Fusion Health and Vitality LLC

Recalled Item: Immune Boost with natural strawberry flavor Recalled by Fusion Health and...

The Issue: Marketed without an Approved NDA/ANDA: Product marketed with drug claims.

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

Class II — Potential Health HazardOngoing
Refund
DrugNovember 18, 2020· The Harvard Drug Group

Recalled Item: Aripiprazole Tablets Recalled by The Harvard Drug Group Due to Failed...

The Issue: Failed Dissolution Specifications: Out of specification for dissolution.

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceSeed" Prostate Cryoablation Kit Recalled by Boston Scientific Corporation...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceRod" He-Thaw Prostate Cryoablation Kit Recalled by Boston Scientific...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceFORCE" 2.1 CX L 90¿ Cryoablation Needle Recalled by Boston Scientific...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Becton Dickinson & Company

Recalled Item: BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) Recalled by Becton...

The Issue: BD has confirmed the presence of blood on the cannulas of the BD...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Shimadzu Medical Systems

Recalled Item: Bransist Safire Recalled by Shimadzu Medical Systems Due to The firm has...

The Issue: The firm has identified a problem with the control software for the celling...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Philips North America Llc

Recalled Item: Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended...

The Issue: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceRod" 1.5 Cryoablation Needle Recalled by Boston Scientific Corporation...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceRod" Prostate Cryoablation Kit Recalled by Boston Scientific Corporation...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: Five IceRod" i-Thaw" Prostate Cryoablation Kit Recalled by Boston Scientific...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Aesculap Implant Systems LLC

Recalled Item: ENNOVATE MIS REMOVALKEY SHORT Recalled by Aesculap Implant Systems LLC Due...

The Issue: Fracture or breakage of the spinal fixation arm at the downtube instrument...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Boston Scientific Corporation

Recalled Item: IceRod" 1.5 PLUS 90¿ Cryoablation Needle Recalled by Boston Scientific...

The Issue: Complaint trend regarding needle shaft gas leaks.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2020· Shimadzu Medical Systems

Recalled Item: MH-200S Recalled by Shimadzu Medical Systems Due to The firm has identified...

The Issue: The firm has identified a problem with the control software for the celling...

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

Class II — Potential Health HazardOngoing