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. 2,460 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,460 in last 12 months

Showing 1698117000 of 48,770 recalls

Medical DeviceSeptember 22, 2020· Gordian Surgical

Recalled Item: TroClose 1200 - Product Usage: intended for use in a variety of gynecologic...

The Issue: Endotoxin test results found above the acceptable levels in LAL test (above...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Pentax of America Inc

Recalled Item: 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal) Recalled by Pentax...

The Issue: There is an intermittent software issue that could affect the systems, in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Boston Scientific Corporation

Recalled Item: Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI...

The Issue: Incorrectly installed base.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 22, 2020· Pentax of America Inc

Recalled Item: 9310HD Digital Video Capture Module with software version 3.4.0 or Recalled...

The Issue: There is an intermittent software issue that could affect the systems, in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2020· GE Healthcare, LLC

Recalled Item: Revolution Apex Recalled by GE Healthcare, LLC Due to There is a potential...

The Issue: There is a potential for a smudge artifact that could be suspect for...

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

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

Recalled Item: Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray...

The Issue: Potential malfunction in which the examination room monitor may become...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 21, 2020· Smith & Nephew, Inc.

Recalled Item: Genesis (GII) - Product Usage: designed for use in patients Recalled by...

The Issue: The anterior locking detail does not meet its design specifications.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 18, 2020· Siemens Medical Solutions USA, Inc

Recalled Item: ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage:...

The Issue: There is a software problem which affects the DSA Roadmap application on...

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

Class II — Potential Health HazardOngoing
DrugSeptember 17, 2020· Acella Pharmaceuticals, LLC

Recalled Item: NP Thyroid 15 Recalled by Acella Pharmaceuticals, LLC Due to Subpotent Drug:...

The Issue: Subpotent Drug: FDA analysis found these products to be less than the...

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

Class I — Serious Health HazardOngoing
Refund
DrugSeptember 17, 2020· Acella Pharmaceuticals, LLC

Recalled Item: NP Thyroid 120 Recalled by Acella Pharmaceuticals, LLC Due to Subpotent...

The Issue: Subpotent Drug: FDA analysis found these products to be less than the...

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceSeptember 17, 2020· Genicon, Inc.

Recalled Item: A Li-Gator Single Use Laparoscopic Clip Applier Recalled by Genicon, Inc....

The Issue: Device malfunction causing the applier to jam, and clip loading failures.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 17, 2020· Quidel Corporation

Recalled Item: Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen Recalled by...

The Issue: Instructions for use in the package insert for SARS Antigen FIA test were...

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

Class II — Potential Health HazardOngoing
DrugSeptember 16, 2020· Arbor Pharmaceuticals Inc.

Recalled Item: Nymalize (nimodipine) oral solution Recalled by Arbor Pharmaceuticals Inc....

The Issue: Subpotent Drug

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

Class III — Low RiskOngoing
Refund
DrugSeptember 16, 2020· Perrigo Company PLC

Recalled Item: Albuterol Sulfate Inhalation Aerosol Recalled by Perrigo Company PLC Due to...

The Issue: Defective Delivery System: Sustained trend of failure to dispense complaints.

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 16, 2020· Merit Medical Systems, Inc.

Recalled Item: MeritMedical Cultura Flex Swab Recalled by Merit Medical Systems, Inc. Due...

The Issue: The flocked tip of the 100mm swab may break off in the nasophyaryngeal...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2020· Merit Medical Systems, Inc.

Recalled Item: Merit Medical Cultura Collection and Transport System Recalled by Merit...

The Issue: The flocked tip of the 100mm swab may break off in the nasophyaryngeal...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2020· Merit Medical Systems, Inc.

Recalled Item: Merit Medical Cultura Collection and Transport System Recalled by Merit...

The Issue: The flocked tip of the 100mm swab may break off in the nasophyaryngeal...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 16, 2020· Boston Scientific Corporation

Recalled Item: Hurricane RX Biliary Balloon Dilatation Catheter Catalog . M00545890...

The Issue: RX tunnel component (black sheath) may detach from the catheter shaft due to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2020· 3M Company - Health Care Business

Recalled Item: 3M Red Dot Monitoring Electrode with Foam Tape - Product Recalled by 3M...

The Issue: Corrosion could cause performance failures in the product.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 15, 2020· 3M Company - Health Care Business

Recalled Item: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Recalled by...

The Issue: Corrosion could cause performance failures in the product.

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

Class II — Potential Health HazardOngoing