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. 2,518 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,518 in last 12 months

Showing 1048110500 of 27,655 recalls

Medical DeviceNovember 23, 2020· Baxter Healthcare Corporation

Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version...

The Issue: There is a potential software error during programming.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Ortho-Clinical Diagnostics, Inc.

Recalled Item: enGen Laboratory Automation System Recalled by Ortho-Clinical Diagnostics,...

The Issue: A software anomaly may cause an aliquoted sample to be labelled as the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Automation Solutions Recalled by Ortho-Clinical Diagnostics, Inc. Due...

The Issue: A software anomaly may cause an aliquoted sample to be labelled as the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Zimmer Biomet, Inc.

Recalled Item: Spinal Rod Cutter Recalled by Zimmer Biomet, Inc. Due to Device has the...

The Issue: Device has the potential for fracture during use.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Haag-Streit USA Inc

Recalled Item: Haag Streit Surgical Floor stands FS 2-11 (. 615H511) Recalled by...

The Issue: Software error -Software 588 versions 2.0 to 3.3, movement of the focusing...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: HLS Set Advanced Model Name: BEQ-HLS 5050 USA Recalled by Maquet...

The Issue: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: HLS Set Advanced Recalled by Maquet Cardiovascular Us Sales, Llc Due to The...

The Issue: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to...

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· Steris Corporation

Recalled Item: Medisafe Distal Duck Kit and Duck Bag Recalled by Steris Corporation Due to...

The Issue: STERIS has identified that certain lots of diluted 4-Zyme may contain...

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

Class II — Potential Health HazardOngoing
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· Philips North America, LLC

Recalled Item: Emission Computed Tomography System Image Process System - Product Usage:...

The Issue: A software defect that has the potential to result in image misdiagnosis and...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2020· Lidco Ltd

Recalled Item: CM 50-001-01 Injectate Kit Recalled by Lidco Ltd Due to The expiration date...

The Issue: The expiration date on labeling is incorrect.

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 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 18.0MM 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
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
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 15.0MM 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 13.0MM 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
Medical DeviceNovember 19, 2020· Medtronic Neuromodulation

Recalled Item: Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept...

The Issue: A software anomaly in the A620 Patient Programmer application was identified...

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 16.0MM 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