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 1068110700 of 27,655 recalls

Medical DeviceOctober 27, 2020· Mani, Inc. - Kiyohara Facility

Recalled Item: MANI Infusion Cannula 23G S - Product Usage: for use Recalled by Mani, Inc....

The Issue: Dimensions of the Luer connector parts out of specification, may cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 27, 2020· Mani, Inc. - Kiyohara Facility

Recalled Item: MANI TROCAR KIT 23G S - Product Usage: for use Recalled by Mani, Inc. -...

The Issue: Dimensions of the Luer connector parts out of specification, may cause...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1300 Analyzer - Product Usage: automated Recalled by Siemens...

The Issue: Test Definition scanning may reset custom settings to defaults causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 26, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1600 Analyzer - Product Usage: automated Recalled by Siemens...

The Issue: Test Definition scanning may reset custom settings to defaults. When a 2D...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Hardy Diagnostics

Recalled Item: Viral Transport Medium Recalled by Hardy Diagnostics Due to There is a...

The Issue: There is a potential for contamination within Viral Transport Media. Use of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) PRO+ System. With the following model numbers: a. Recalled by...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Medtronic Heart Valves Division

Recalled Item: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23...

The Issue: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Biomeme, Inc.

Recalled Item: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in Recalled by...

The Issue: The firm has become aware of nine reports by a single customer that the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Becton Dickinson & Company

Recalled Item: BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for Recalled by Becton...

The Issue: Product shelf cartons incorrectly labeled as products intended for the Latin...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Intuitive Surgical, Inc.

Recalled Item: Box Label: ION Fully Articulating Catheter Recalled by Intuitive Surgical,...

The Issue: The distal tip ring of the fully articulating catheter may become dislodged...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Coloplast Manufacturing US, LLC

Recalled Item: Titan Pump - Product Usage: indicated for male patients suffering Recalled...

The Issue: Potential increased occurrence of pump fracture over the lifetime of the device.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 23, 2020· Mako Surgical Corporation

Recalled Item: Mako Integrated Cutting System (MICS) Handpiece Recalled by Mako Surgical...

The Issue: Stryker has discovered a characterization issue associated with the Mako...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 21, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee floor Recalled by Siemens Medical Solutions USA, Inc Due to Some...

The Issue: Some electronic components within the generator were equipped with an...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 20, 2020· Viewray, Inc.

Recalled Item: ViewRay MRIdian System: Model No. 10000 Recalled by Viewray, Inc. Due to...

The Issue: There is a potential that components of the receive coil can reach elevated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 20, 2020· Viewray, Inc.

Recalled Item: ViewRay MRIdian Linac System: Model No. 20000 Recalled by Viewray, Inc. Due...

The Issue: There is a potential that components of the receive coil can reach elevated...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 19, 2020· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone Recalled by...

The Issue: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 19, 2020· Mevion Medical Systems, Inc.

Recalled Item: MEVION S250i Recalled by Mevion Medical Systems, Inc. Due to Treatment beam...

The Issue: Treatment beam information disappears on Treatment Console screen while beam...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 19, 2020· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone Recalled...

The Issue: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 19, 2020· Geistlich Pharma North America, Inc.

Recalled Item: Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone Recalled...

The Issue: Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could...

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

Class II — Potential Health HazardOngoing