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 1096110980 of 27,655 recalls

Medical DeviceAugust 31, 2020· ICU Medical, Inc.

Recalled Item: 42 IN (107 cm) Appx 5.0 ml Recalled by ICU Medical, Inc. Due to Potential...

The Issue: Potential for spinning versions of male luers to exhibit leaks due to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· ICU Medical, Inc.

Recalled Item: 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber...

The Issue: Potential for spinning versions of male luers to exhibit leaks due to a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001...

The Issue: Potential for Fluid leaks within the instruments, creating an electrical...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Greiner Bio-One North America, Inc.

Recalled Item: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator Recalled by Greiner...

The Issue: Blood collection tubes experienced an issue with separation and clotting

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 28, 2020· Siemens Healthcare Diagnostics Inc

Recalled Item: Siemens epoc BGEM Test Card-In vitro diagnostic device for the Recalled by...

The Issue: Sporadically inconsistent discrepant (low bias) glucose results on card lot...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Albumin Gen.2 Recalled by Roche Diagnostics Operations, Inc. Due to Roche...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

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

Class III — Low RiskOngoing
Medical DeviceAugust 27, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Tina-quant Complement C4 ver.2 Recalled by Roche Diagnostics Operations,...

The Issue: Roche has confirmed customer complaints of low quality (QC) recovery and...

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

Class III — Low RiskOngoing
Medical DeviceAugust 26, 2020· Beckman Coulter Inc.

Recalled Item: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol...

The Issue: Due to alkaline phosphatase (ALP) associated interference causing falsely...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge -...

The Issue: Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x1/16 UAS BLK...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 3/8x3/32 Recalled...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Genicon, Inc.

Recalled Item: Aquas PowerFlow Tube Set - Product Usage: The device delivers Recalled by...

The Issue: The product design incorporating a motor driven impeller pump powered by one...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM HER-2/neu (H2n) assay Recalled by Siemens Healthcare...

The Issue: Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 25, 2020· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Ultrasonic Air Sensor 1/4x3/32 Recalled...

The Issue: Internal testing at the supplier, revealed that a crimped wire was placed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 25, 2020· Medtronic Vascular

Recalled Item: Rashkind Balloon Septostomy Catheter Recalled by Medtronic Vascular Due to...

The Issue: Subsequent failure of catheters in the field and failed quality testing

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 24, 2020· Irvine Biomedical Inc, a St. Jude Medical Co.

Recalled Item: Inquiry Steerable Diagnostic Catheter Recalled by Irvine Biomedical Inc, a...

The Issue: Steerable diagnostic catheter packages labeled Model IBI-81104, batch...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 24, 2020· Exactech, Inc.

Recalled Item: Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm....

The Issue: Exactech is recalling the Equinoxe Reverse Shoulder Compression...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 24, 2020· Alcon Research, LLC

Recalled Item: Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health"...

The Issue: The third-party brand latex micro surgical gloves packaged within specific...

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

Class II — Potential Health HazardOngoing