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 1848118500 of 48,770 recalls

Medical DeviceMarch 31, 2020· Spectranetics Corporation

Recalled Item: Bridge Occlusion Balloon Recalled by Spectranetics Corporation Due to There...

The Issue: There is a potential for thrombus formation on balloons prepped and staged...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 31, 2020· Becton, Dickinson and Company, BD Biosciences

Recalled Item: Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US) Recalled by...

The Issue: False positive reaction on the reagent.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Beckman Coulter Inc.

Recalled Item: iChem¿VELOCITY Urine Chemistry System- Recalled by Beckman Coulter Inc. Due...

The Issue: A defect in the SATA power adapter cable within the instruments computer has...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Beckman Coulter Inc.

Recalled Item: iQ200 Series Urine Microscopy Analyzer- All part numbers Recalled by Beckman...

The Issue: A defect in the SATA power adapter cable within the instrument s computer...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Boston Scientific Corporation

Recalled Item: MoXy Laser Fiber Recalled by Boston Scientific Corporation Due to To...

The Issue: To reinforce existing instructions within the Directions for Use (DFU) and...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 30, 2020· Elekta Inc

Recalled Item: Leksell Vantage Stereotactic System. Instrument Carrier Recalled by Elekta...

The Issue: A faulty locking piece of the Instrument Carrier that does not fulfil the...

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

Class II — Potential Health HazardOngoing
DrugMarch 26, 2020· Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Recalled Item: Testosterone Cypionate In Sesame Oil 200mg/ml Recalled by Innovative...

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
DrugMarch 26, 2020· Avet Pharmaceuticals, Inc.

Recalled Item: Losartan Potassium Tablets USP 100 mg Recalled by Avet Pharmaceuticals, Inc....

The Issue: CGMP Deviations: FDA lab confirmed presence of an impurity,...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 26, 2020· Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Recalled Item: MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) Recalled...

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
DrugMarch 26, 2020· Avet Pharmaceuticals, Inc.

Recalled Item: Losartan Potassium Tablets USP 50 mg Recalled by Avet Pharmaceuticals, Inc....

The Issue: CGMP Deviations: FDA lab confirmed presence of an impurity,...

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

Class II — Potential Health HazardOngoing
Refund
DrugMarch 26, 2020· Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Recalled Item: Methylcobalamin Soln. 1000 mcg/ml Recalled by Innovative Intrathecal...

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
DrugMarch 26, 2020· Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Recalled Item: Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln Recalled by...

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
DrugMarch 26, 2020· Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Recalled Item: Hydroxyprogesterone Caproate (BUD) 350mg/ml Recalled by Innovative...

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 DeviceMarch 26, 2020· Shanghai United Imaging Healthcare Co., Ltd.

Recalled Item: Positron Emission Tomography and Computed Tomography System Recalled by...

The Issue: In affected software version, of Positron emission tomography and computed...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Medtronic Sofamor Danek USA Inc

Recalled Item: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628...

The Issue: Nonconforming product; length of the product measured shorter than the...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 26, 2020· Gentell, Inc

Recalled Item: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing...

The Issue: During an FDA audit, it was discovered that the product was not properly...

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

Class II — Potential Health HazardOngoing
DrugMarch 25, 2020· Akorn Inc

Recalled Item: Fentanyl Citrate Injection Recalled by Akorn Inc Due to Failed...

The Issue: Failed impurities/degradation specification: Out-of-Specification result for...

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

Class III — Low RiskOngoing
Refund