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. 2,379 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,379 in last 12 months

Showing 2368123700 of 48,770 recalls

Medical DeviceSeptember 6, 2018· Stihler Electronic Gmbh

Recalled Item: Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Recalled...

The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stihler Electronic Gmbh

Recalled Item: Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product...

The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stryker Medical Division of Stryker Corporation

Recalled Item: Altrix¿ Precision Temperature Management System Model: 8001Product Usage:...

The Issue: Users may experience alarm fatigue due to frequent alarming relating to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· CryoLife, Inc.

Recalled Item: CryoPatch SG Pulmonary Hemi-Artery Recalled by CryoLife, Inc. Due to The...

The Issue: The conduit length and branch length of a SG Pulmonary Hemi-Artery were...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· Cordis Corporation

Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is Recalled by...

The Issue: Product may not meet the internal manufacturing shaft subassembly burst...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· BioFire Diagnostics, LLC

Recalled Item: FilmArray Blood Culture Identification (BCID) Recalled by BioFire...

The Issue: Increased risk of false positive results for Proteus when the product is...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· Thoratec Switzerland GMBH

Recalled Item: Thoratec CentriMag Motor Recalled by Thoratec Switzerland GMBH Due to...

The Issue: Reports of circulatory support system motor stopping. Motor stop can be...

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

Class II — Potential Health HazardOngoing
DrugSeptember 4, 2018· Boehringer Ingelheim Pharmaceuticals, Inc.

Recalled Item: Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg....

The Issue: Cross Contamination With Other Products:

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 4, 2018· Dr. Reddy's Laboratories, Inc.

Recalled Item: Tizanidine HCl Tablets Recalled by Dr. Reddy's Laboratories, Inc. Due to...

The Issue: Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 4, 2018· Alpha Omega Engineering

Recalled Item: Neuro Omega System Recalled by Alpha Omega Engineering Due to If cables are...

The Issue: If cables are improperly connected, current may reach high charge density,...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 4, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Vereos PET/CT Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: Software Correction: Software errors that may result in incorrect 4D CT...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· Cypress Medical Products LLC

Recalled Item: McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P...

The Issue: Small hole at the end of the syringe is impeding suction of liquid.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· CooperSurgical, Inc.

Recalled Item: Colpo-Pneumo Occluder Recalled by CooperSurgical, Inc. Due to The seal of...

The Issue: The seal of the sterile pouch may be compromised, thereby increasing the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· GE Healthcare Finland Oy

Recalled Item: GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of...

The Issue: When multiple CARESCAPEMonitor B450 or B850 units are connected to the same...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· GE Healthcare Finland Oy

Recalled Item: GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of...

The Issue: When multiple CARESCAPEMonitor B450 or B850 units are connected to the same...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· Cincinnati Sub-Zero Products LLC, a Gentherm Company

Recalled Item: Hemotherm 400CE Recalled by Cincinnati Sub-Zero Products LLC, a Gentherm...

The Issue: Potential for membrane (control panel) switch errors leading to an inability...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· CooperSurgical, Inc.

Recalled Item: Retractor System Elastic Stays (Part 3314-lG Recalled by CooperSurgical,...

The Issue: There is a possibility that the seal of the sterile pouch may be...

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

Class II — Potential Health HazardOngoing
DrugAugust 31, 2018· BioLyte Laboratories, LLC

Recalled Item: NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel...

The Issue: CGMP Deviations: finished product produced with active ingredients recalled...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 31, 2018· Beaumont Bio-med, Inc.

Recalled Item: Skin Irritation & Itch Response Homeopathic Formula Recalled by Beaumont...

The Issue: CGMP Deviations: products manufactured by contract manufacturer under...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 31, 2018· Beaumont Bio-med, Inc.

Recalled Item: Diarrhea Response Homeopathic Formula Recalled by Beaumont Bio-med, Inc. Due...

The Issue: CGMP Deviations: products manufactured by contract manufacturer under...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund