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. 2,524 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,524 in last 12 months

Showing 82218240 of 27,655 recalls

Medical DeviceMarch 2, 2022· Medtronic Inc

Recalled Item: Harmony Delivery Catheter System. Part of the Harmony Transcatheter...

The Issue: There is potential for the capsule bond to break during the procedure.

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

Class I — Serious Health HazardOngoing
Medical DeviceMarch 1, 2022· Merit Medical Systems, Inc.

Recalled Item: AccessPLUS Large Bore Hemostasis Valves Recalled by Merit Medical Systems,...

The Issue: A design change made to a hemostasis valve to improve manufacturability...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2022· Merit Medical Systems, Inc.

Recalled Item: Access-9 Large Bore Hemostasis Valves Recalled by Merit Medical Systems,...

The Issue: A design change made to a hemostasis valve to improve manufacturability...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2022· Edwards Lifesciences, LLC

Recalled Item: FORE-SIGHT ELITE Absolute Tissue Oximeter Recalled by Edwards Lifesciences,...

The Issue: The StO2 values may be inaccurately low when using either the FORE-SIGHT...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2022· Edwards Lifesciences, LLC

Recalled Item: FORE-SIGHT ELITE Tissue Oximeter module Recalled by Edwards Lifesciences,...

The Issue: The StO2 values may be inaccurately low when using either the FORE-SIGHT...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2022· MALVERN PANALYTICAL LTD

Recalled Item: NanoSight LM10 fitted with LM12 module. A laboratory instrument for Recalled...

The Issue: Product found to not comply to Class 1 Laser safety requirement.

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2022· MALVERN PANALYTICAL LTD

Recalled Item: NanoSight LM10 fitted with LM14 module. A laboratory instrument for Recalled...

The Issue: Product found to not comply to Class 1 Laser safety requirement.

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2022· Medtronic Neuromodulation

Recalled Item: MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL Recalled by Medtronic...

The Issue: There is a software anomaly with the InterStim X Clinician software...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2022· Respironics California, LLC

Recalled Item: Philips Respironics V680 Ventilator (All Models Recalled by Respironics...

The Issue: Ventilator units have an issue impacting an internal electrical circuit...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 28, 2022· Respironics California, LLC

Recalled Item: Philips Respironics V60 Plus Ventilator (All Models Recalled by Respironics...

The Issue: Ventilator units have an issue impacting an internal electrical circuit...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 28, 2022· Respironics California, LLC

Recalled Item: Philips Respironics V60 Ventilator (All Models Recalled by Respironics...

The Issue: Ventilator units have an issue impacting an internal electrical circuit...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 28, 2022· Integra LifeSciences Corp.

Recalled Item: Integra Universal Flexible Arm part number Recalled by Integra LifeSciences...

The Issue: Excess force used to tighten the Universal Flexible Arm can cause the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Philips North America Llc

Recalled Item: DigitalDiagnost C50 1.1 Recalled by Philips North America Llc Due to...

The Issue: Following a system restart where the Table Height 2 (TH2) is the default...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Siemens Medical Solutions USA, Inc

Recalled Item: syngo Application software VE20 (Material Number 10848815) installed on the...

The Issue: After CT image data from Toshiba is loaded, image mirroring can occur along...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Siemens Medical Solutions USA, Inc

Recalled Item: Artis icono floor in combination with a Siemens Healthineers table Recalled...

The Issue: Five potential software issues affecting Artis pheno and Artis icono systems...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Siemens Medical Solutions USA, Inc

Recalled Item: Artis icono biplane- in combination with a Siemens Healthineers table...

The Issue: Five potential software issues affecting Artis pheno and Artis icono systems...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Siemens Medical Solutions USA, Inc

Recalled Item: Artis pheno- in combination with a Siemens Healthineers table or Recalled by...

The Issue: Five potential software issues affecting Artis pheno and Artis icono systems...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Baxter Healthcare Corporation

Recalled Item: Baxter DISCPAC Syringe Tip Caps Recalled by Baxter Healthcare Corporation...

The Issue: Product is mislabeled as self-righting Luer slip tip caps, yellow.

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Stradis Medical, LLC dba Stradis Healthcare

Recalled Item: Anterior Hip Pack - Surgical Kit Recalled by Stradis Medical, LLC dba...

The Issue: The outer bag may be perforated or torn, which may result in a breach in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 25, 2022· Stradis Medical, LLC dba Stradis Healthcare

Recalled Item: Coryell Memorial Hosp Total Recalled by Stradis Medical, LLC dba Stradis...

The Issue: The outer bag may be perforated or torn, which may result in a breach in the...

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

Class II — Potential Health HazardOngoing