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. 2,499 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,499 in last 12 months

Showing 1324113260 of 48,770 recalls

Medical DeviceJanuary 14, 2022· Maquet Cardiovascular, LLC

Recalled Item: HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm...

The Issue: Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2022· Sunstar Americas, Inc.

Recalled Item: BUTLER Clear Dip Recalled by Sunstar Americas, Inc. Due to Product lacks...

The Issue: Product lacks premarket clearance.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2022· K2M, Inc

Recalled Item: Everest MI XT Inner Dilator Recalled by K2M, Inc Due to Stryker received two...

The Issue: Stryker received two (2) complaints for units from specific lots of Inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· Nextremity Solutions

Recalled Item: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone...

The Issue: During insertion of the middle phalanx implant into bone, the driver may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2022· Nextremity Solutions

Recalled Item: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone...

The Issue: During insertion of the middle phalanx implant into bone, the driver may...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: LuSys 2nd Generation of COVID-19 Viral Antigen Test For all Recalled by...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· Lusys Laboratories, Inc.

Recalled Item: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and Recalled by...

The Issue: COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 13, 2022· K2M, Inc

Recalled Item: Everest MI XT Outer Dilator Recalled by K2M, Inc Due to Stryker received two...

The Issue: Stryker received two (2) complaints for units from specific lots of Inner...

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

Class II — Potential Health HazardOngoing
DrugJanuary 12, 2022· Ascend Laboratories, LLC

Recalled Item: Metoprolol Succinate Extended-Release Tablets Recalled by Ascend...

The Issue: Failed Dissolution Specifications.

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 11, 2022· Exela Pharma Sciences LLC

Recalled Item: 8.4% Sodium Bicarbonate Injection Recalled by Exela Pharma Sciences LLC Due...

The Issue: Lack of Assurance of Sterility

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: 5 Fr. X 65 cm Arrow-Trerotola PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) Recalled by...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) Recalled by...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 11, 2022· TELEFLEX MEDICAL INC

Recalled Item: Arrow-Trerotola Over-The-Wire PTD Kit Recalled by TELEFLEX MEDICAL INC Due...

The Issue: The firm received reports indicating PTD tip separation during use.

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

Class I — Serious Health HazardOngoing
DrugJanuary 10, 2022· Teva Pharmaceuticals USA

Recalled Item: Tretinoin Capsules Recalled by Teva Pharmaceuticals USA Due to Failed...

The Issue: Failed Dissolution Specifications; Low Out of specification (OOS) results...

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 10, 2022· Ingenus Pharmaceuticals Llc

Recalled Item: Clobetasol Propionate Foam Recalled by Ingenus Pharmaceuticals Llc Due to...

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund