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. 2,515 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,515 in last 12 months

Showing 1164111660 of 48,770 recalls

Medical DeviceJune 22, 2022· Intuitive Surgical, Inc.

Recalled Item: The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit...

The Issue: Due to preventative maintenance (PM) not being performed on E-100 generators...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2022· Meridian Bioscience Inc

Recalled Item: Revogene Recalled by Meridian Bioscience Inc Due to When a run is aborted,...

The Issue: When a run is aborted, the cooling period protection does not occur and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 22, 2022· Integra LifeSciences Corp.

Recalled Item: CereLink ICP Monitor Recalled by Integra LifeSciences Corp. Due to Integra...

The Issue: Integra has received complaints associated with ICP readings drifting to -50...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 22, 2022· Randox Laboratories Ltd.

Recalled Item: Randox Cholesterol- For the quantitative in vitro determination of...

The Issue: Product fails to meet the performance claims quoted on the kit insert:...

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

Class II — Potential Health HazardOngoing
DrugJune 21, 2022· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Esomeprazole Magnesium Delayed-Release Capsules Recalled by SUN...

The Issue: Superpotent Drug: Out of specification for assay at the 12-month timepoint.

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

Class III — Low RiskOngoing
Refund
DrugJune 21, 2022· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Esomeprazole Magnesium Delayed-Release Capsules Recalled by SUN...

The Issue: Superpotent Drug: Out of specification for assay at the 12-month timepoint.

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

Class III — Low RiskOngoing
Refund
DrugJune 21, 2022· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Testosterone Cypionate Injection Recalled by SUN PHARMACEUTICAL INDUSTRIES...

The Issue: cGMP - Water leakage

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJune 21, 2022· Fresenius Medical Care Holdings, Inc.

Recalled Item: AquaC UNO H [120V Recalled by Fresenius Medical Care Holdings, Inc. Due to...

The Issue: Internal ethemet cables are missing one or both ferrite cores therefore the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2022· Fresenius Medical Care Holdings, Inc.

Recalled Item: AquaC UNO H [120V Recalled by Fresenius Medical Care Holdings, Inc. Due to...

The Issue: Internal ethemet cables are missing one or both ferrite cores therefore the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 21, 2022· Touch US Llc

Recalled Item: etouchus Recalled by Touch US Llc Due to Device was marketed without FDA...

The Issue: Device was marketed without FDA 510(k) clearance or a PMA.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 20, 2022· Bard Access Systems, Inc.

Recalled Item: Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit...

The Issue: BD Intraosseous Needle Kits may exhibit: 1) Increased force required to...

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

Class I — Serious Health HazardOngoing
FoodJune 17, 2022· DAILY HARVEST

Recalled Item: Daily Harvest French Lentil + leek Crumbles Recalled by DAILY HARVEST Due to...

The Issue: Product is linked to complaints of gastrointestinal illness.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJune 17, 2022· Luminex Corporation

Recalled Item: Verigene CDF Nucleic Acid Test Recalled by Luminex Corporation Due to There...

The Issue: There is a potential for false negative results using VERIGENE CDF Stool...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2022· St. Jude Medical, Cardiac Rhythm Management Division

Recalled Item: Merlin 2 PCS MER37000 programmer Model MER3400 software Recalled by St. Jude...

The Issue: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2022· St. Jude Medical, Cardiac Rhythm Management Division

Recalled Item: Merlin PCS 3650 programmer Model 3330 software Recalled by St. Jude Medical,...

The Issue: There is a potential for programmer software (Merlin PCS) and remote...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2022· St. Jude Medical, Cardiac Rhythm Management Division

Recalled Item: Merlin.net model MN5000 Software Recalled by St. Jude Medical, Cardiac...

The Issue: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 17, 2022· Luminex Corporation

Recalled Item: VERIGENE Enteric Pathogens Nucleic Acid Test Recalled by Luminex Corporation...

The Issue: There is a potential for false negative results using VERIGENE CDF Stool...

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

Class II — Potential Health HazardOngoing
DrugJune 16, 2022· Jubilant Draximage Inc

Recalled Item: Draximage MAA (Kit for the preparation of Technnetium Tc 99m Recalled by...

The Issue: Lack of Assurance of Sterility: Out-of-specification test results obtained...

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

Class II — Potential Health HazardOngoing
Refund
DrugJune 16, 2022· Macleods Pharma Usa Inc

Recalled Item: Eszopiclone Tablets Recalled by Macleods Pharma Usa Inc Due to Shortfill:...

The Issue: Shortfill: customer complaints of one to three tablets were reported missing...

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

Class II — Potential Health HazardOngoing
Refund
DrugJune 16, 2022· Glenmark Pharmaceuticals Inc., USA

Recalled Item: Mometasone Furoate Recalled by Glenmark Pharmaceuticals Inc., USA Due to...

The Issue: Defective Container

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

Class III — Low RiskOngoing
Refund