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

48,770 total recalls
2,520 in last 12 months

Showing 99619980 of 27,655 recalls

Medical DeviceMarch 4, 2021· Covidien, LP

Recalled Item: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Recalled...

The Issue: Potential for the device safety interlock to fail. The safety interlock...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2021· Covidien, LP

Recalled Item: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Recalled...

The Issue: Potential for the device safety interlock to fail. The safety interlock...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2021· Covidien, LP

Recalled Item: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30...

The Issue: Potential for the device safety interlock to fail. The safety interlock...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 4, 2021· ROi CPS LLC

Recalled Item: Regard Recalled by ROi CPS LLC Due to ROi CPS, LLC has become aware, through...

The Issue: ROi CPS, LLC has become aware, through a vendor issued urgent medical device...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2021· p-Chip Corporation

Recalled Item: p-Chip Wand Reader Recalled by p-Chip Corporation Due to The laser operation...

The Issue: The laser operation might fall under a higher laser class.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2021· CareFusion 303, Inc.

Recalled Item: BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad Recalled by...

The Issue: Pump Module keypad lifting, and Fluid ingress could result in 1)...

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

Class I — Serious Health HazardOngoing
Medical DeviceMarch 3, 2021· Medtronic Perfusion Systems

Recalled Item: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console Recalled by...

The Issue: An electrical component within the system controller module of certain...

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

Class I — Serious Health HazardOngoing
Medical DeviceMarch 3, 2021· RAYSEARCH LABORATORIES AB

Recalled Item: RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information...

The Issue: Patient related messages created in RayCare 3B, RayCare 4A will be lost when...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 3, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed...

The Issue: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 2, 2021· Siemens Healthcare Diagnostics, Inc.

Recalled Item: BCS XP System: Multipurpose system for in vitro coagulation studies....

The Issue: Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 2, 2021· AZURE BIOTECH INC

Recalled Item: Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Recalled by...

The Issue: Due to Products being incorrect labeling "for diagnostic use" and labelled...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 2, 2021· Terumo Cardiovascular Systems Corporation

Recalled Item: Consist of a distal connection mechanism (either standard Terumo Ball...

The Issue: There is a potential for the stainless steel locking plates on the device's...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 2, 2021· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: Synapse PACS - Radiological Image Processing System - Product Usage:...

The Issue: The wrong patient information may be displayed in the viewer or PowerJacket.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2021· Abiomed, Inc.

Recalled Item: Automated Impella Controller (AIC) Recalled by Abiomed, Inc. Due to...

The Issue: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2021· Cellex

Recalled Item: Cellex qSARS-Cov-2 Antigen Rapid Test Recalled by Cellex Due to The kit does...

The Issue: The kit does not have an emergency use authorization (EUA).

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2021· James Leckey Design Ltd

Recalled Item: MyWay Walker Chassis - Product Usage: is intended for use Recalled by James...

The Issue: Due to a failure of the welds, the casters detached from the rear legs of...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2021· Hitachi Medical Systems America Inc

Recalled Item: Ultrasonic pulsed doppler imaging system - Product Usage: intended for...

The Issue: Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2021· Heartware, Inc.

Recalled Item: Instructions for Use and Patient Manual for HeartWare HVAD System. Recalled...

The Issue: IFU and Patient Manual updated to describe HVAD Controller Connection...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2021· Heartware, Inc.

Recalled Item: Instructions for Use and Patient Manual for HeartWare HVAD System. Recalled...

The Issue: IFU and Patient Manual updated to describe Expected Alarm Duration. The...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 26, 2021· Heartware, Inc.

Recalled Item: Instructions for Use and Patient Manual for HeartWare HVAD System. Recalled...

The Issue: Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient...

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

Class I — Serious Health HazardOngoing