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. 2,366 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,366 in last 12 months

Showing 2406124080 of 27,655 recalls

Medical DeviceFebruary 14, 2014· Philips Medical Systems, Inc.

Recalled Item: Philips HeartStart XL Recalled by Philips Medical Systems, Inc. Due to...

The Issue: Philips HeartStart XL may experience a power board failure causing failure...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 14, 2014· Horiba Instruments, Inc dba Horiba Medical

Recalled Item: Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s):...

The Issue: HORIBA Medical initiated this recall of all software versions of ABX PENTRA...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 14, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Optima CT580/Discovery CT590RT scanners running software...

The Issue: GE Healthcare has recently become aware of a potential safety issue due to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 14, 2014· RAYSEARCH LABORATORIES AB

Recalled Item: RaySearch Ray Station Radiation Therapy Treatment Planning System Recalled...

The Issue: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0,...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2014· Accumetrics Inc

Recalled Item: VerifyNow IIb/IIIa Test Recalled by Accumetrics Inc Due to Accumetrics is...

The Issue: Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 13, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version...

The Issue: GE Healthcare has recently become aware of a potential safety issue with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2014· Abbott Laboratories

Recalled Item: ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL Recalled by...

The Issue: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 12, 2014· Abbott Laboratories

Recalled Item: ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle Recalled by Abbott...

The Issue: Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS BUN UREA NITROGEN For the In vitro quantitative determination Recalled...

The Issue: Marketing the devices outside 510(k) requirements

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Synthes, Inc.

Recalled Item: The Synthes Hohmann Retractor Recalled by Synthes, Inc. Due to The Synthes...

The Issue: The Synthes Hohmann Retractor was mis-etched on the product and package as...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Philips Medical Systems (Cleveland), Inc.

Recalled Item: Pinnacle3 Radiation Therapy Planning (RTP) System Recalled by Philips...

The Issue: Philips Medical Systems have recently determined that a software...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS AST For the In vitro quantitative determination of AST Recalled by AMS...

The Issue: Marketing the devices outside 510(k) requirements

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· AMS Diagnostics, LLC

Recalled Item: AMS URIC ACID For the In vitro quantitative determination of Recalled by AMS...

The Issue: Marketing the devices outside 510(k) requirements

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 11, 2014· Phillips Respironics, Inc.

Recalled Item: Trilogy Ventilators The Respironics Trilogy 100 system provides continuous...

The Issue: Internal testing revealed a potentially defective component on the power...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 10, 2014· Thermedx LLC

Recalled Item: The Thermedx Fluid Management System is designed to provide irrigation...

The Issue: A vendor changed the manufacturing process of a component used in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 10, 2014· Heraeus Kulzer, LLC.

Recalled Item: BencoDental tartar & stain remover ultrasonic cleaning solution Product...

The Issue: As the result of a complaint to Heraeus Kulzer's customer service...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Siemens Medical Solutions USA, Inc

Recalled Item: AXIOM Artis Systems Product usage: Artis zee is a family Recalled by Siemens...

The Issue: Certain units of the AXIOM Artis Systems are using a flat detector cooling...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For...

The Issue: Potential safety issue related to unintended radial detector motion, which...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 7, 2014· Baxter Healthcare Corp.

Recalled Item: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product...

The Issue: Baxter Healthcare Corporation has issued an Urgent Device Correction for the...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 7, 2014· GE Healthcare, LLC

Recalled Item: Elscint APEX Helix Recalled by GE Healthcare, LLC Due to Potential safety...

The Issue: Potential safety issue related to unintended radial detector motion, which...

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

Class II — Potential Health HazardOngoing