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. 2,450 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,450 in last 12 months

Showing 1890118920 of 48,770 recalls

DrugJanuary 15, 2020· Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Recalled Item: Triamcinolone Diacetate Injectable Suspension Recalled by Fusion IV...

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
DrugJanuary 15, 2020· Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Recalled Item: Methylcobalamin Injection Recalled by Fusion IV Pharmaceuticals, Inc. dba...

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
DrugJanuary 15, 2020· Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Recalled Item: Nicotinamide Adenine Dinucleotide (PF) Injection Recalled by Fusion IV...

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
FoodJanuary 15, 2020· The Honest Stand

Recalled Item: Hungry Root Dairy free Garlic Parm sauce Recalled by The Honest Stand Due to...

The Issue: Undeclared Allergen: Product contains both cashews and almonds, but only...

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

Class I — Serious Health HazardOngoing
Refund
Medical DeviceJanuary 15, 2020· Bard Peripheral Vascular Inc

Recalled Item: BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth...

The Issue: The catheter locks for the lot may contain an 8Fr catheter lock instead of a...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Cardinal Health 200, LLC

Recalled Item: Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 Recalled by...

The Issue: Non-sterile product was shipped to customers. Product package is labeled as...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Cardinal Health 200, LLC

Recalled Item: Monoject 3mL Syringe with Hypodermic Safety Needle Recalled by Cardinal...

The Issue: Non-sterile product was shipped to customers. Product package is labeled as...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Cardinal Health 200, LLC

Recalled Item: Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 Recalled by...

The Issue: Non-sterile product was shipped to customers. Product package is labeled as...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Cardinal Health 200, LLC

Recalled Item: Monoject Bluntfill with Filter Recalled by Cardinal Health 200, LLC Due to...

The Issue: Non-sterile product was shipped to customers. Product package is labeled as...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Abbott Point Of Care Inc.

Recalled Item: i-STAT CG4+ cartridge (blue) Recalled by Abbott Point Of Care Inc. Due to...

The Issue: The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2020· Abbott Point Of Care Inc.

Recalled Item: i-STAT CHEM8+ cartridges (blue) Recalled by Abbott Point Of Care Inc. Due to...

The Issue: The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not...

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

Class II — Potential Health HazardOngoing
DrugJanuary 14, 2020· Pharmaceutical Associates Inc

Recalled Item: Nystatin Oral Suspension Recalled by Pharmaceutical Associates Inc Due to...

The Issue: Subpotent: Out of specification for assay at the 12-month time point.

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

Class II — Potential Health HazardOngoing
Refund
DrugJanuary 14, 2020· Hikma Pharmaceuticals USA Inc.

Recalled Item: methylPREDNISolone Sodium Succinate For Injection Recalled by Hikma...

The Issue: Labeling: Incorrect Instructions: Vial label incorrectly instructs...

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

Class III — Low RiskOngoing
Refund
Medical DeviceJanuary 14, 2020· Ormco/Sybronendo

Recalled Item: Ormco Damon Q2 Orthodontic Metal Bracket Recalled by Ormco/Sybronendo Due to...

The Issue: The bracket torque was mislabeled on the packaging.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2020· CME America, LLC

Recalled Item: BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Recalled by...

The Issue: The filter installed onto the tube set may have the incorrect pore size.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2020· Medtronic CoreValve LLC

Recalled Item: Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to Recalled by...

The Issue: Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2020· Medtronic CoreValve LLC

Recalled Item: Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage:...

The Issue: Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2020· Abbott Point Of Care Inc.

Recalled Item: i-STAT G3+ cartridge (blue) Recalled by Abbott Point Of Care Inc. Due to...

The Issue: Marketed without a 510(k). Abbott Point of Care has determined that it does...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2020· Philips North America, LLC

Recalled Item: Philips DigiTrak XT Holter Recorder Software version number B.1 and Recalled...

The Issue: if an AAA battery is inserted in the recorder and a user attempts to start...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2020· Mindray DS USA, Inc. dba Mindray North America

Recalled Item: DP-30 Digital Ultrasonic Diagnostic Imaging System Recalled by Mindray DS...

The Issue: The DP-30 displays an incorrect needle-guide bracket when used with the...

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

Class II — Potential Health HazardOngoing