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 1672116740 of 27,655 recalls

Medical DeviceAugust 18, 2017· Invivo Corporation

Recalled Item: Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive...

The Issue: Intermittent communication between the host system and the FlexCardio

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 18, 2017· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo.plaza Picture Archiving and Communication System (PACS) with software...

The Issue: Software update to correct several issues that include (1)Potential data...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 18, 2017· Olympus Corporation of the Americas

Recalled Item: A20975A "Working insert Recalled by Olympus Corporation of the Americas Due...

The Issue: Olympus has received complaints about fragments of adhesive which detached...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 14, 2017· Merge Healthcare, Inc.

Recalled Item: Merge Unity software Recalled by Merge Healthcare, Inc. Due to The software...

The Issue: The software is not identifying the patient as having atypical hyperplasia,...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 11, 2017· Randox Laboratories

Recalled Item: Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) Recalled by...

The Issue: The ACTH in Immunoassay Premium and Premium Plus quality control does not...

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

Class III — Low RiskOngoing
Medical DeviceAugust 11, 2017· Randox Laboratories

Recalled Item: Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages) Recalled by...

The Issue: The ACTH in Immunoassay Premium and Premium Plus quality control does not...

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

Class III — Low RiskOngoing
Medical DeviceAugust 10, 2017· Synthes USA

Recalled Item: Norian Drillable Inject Recalled by Synthes USA Due to The contract supplier...

The Issue: The contract supplier notified DePuy Synthes on June 16, 2017 that the kit...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 10, 2017· Medline Industries Inc

Recalled Item: Transfer/Gait Belt Recalled by Medline Industries Inc Due to The locking...

The Issue: The locking mechanism on the belt may fail to secure/hold the strap when in...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 10, 2017· Medline Industries Inc

Recalled Item: Transfer/Gait Belt Recalled by Medline Industries Inc Due to The locking...

The Issue: The locking mechanism on the belt may fail to secure/hold the strap when in...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 10, 2017· Aesculap Implant Systems LLC

Recalled Item: NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of...

The Issue: The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 10, 2017· Synthes USA

Recalled Item: Norian Drillable Inject Recalled by Synthes USA Due to The contract supplier...

The Issue: The contract supplier notified DePuy Synthes on June 16, 2017 that the kit...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 10, 2017· Nucletron BV

Recalled Item: Oncentra Brachy 4.5 radiation therapy software The firm name on Recalled by...

The Issue: Incorrect source step size may occur in the software plans

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 9, 2017· CareFusion 303, Inc.

Recalled Item: Alaris Pump Module model 8100 manufactured between November 2011 and March...

The Issue: The recalling firm has received reports of increased or decreased flows that...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 9, 2017· Medtronic Neuromodulation

Recalled Item: Medtronic Synchromed II Model 8637 supplied in 20mL and 40 Recalled by...

The Issue: Medtronic implemented a final design change intended to address the motor...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 8, 2017· LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC

Recalled Item: REVOLVE ADVANCED ADIPOSE SYSTEM Recalled by LifeCell Corporation, A Wholly...

The Issue: Presence of bacterial endotoxins levels above the acceptable limit

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 7, 2017· Zimmer Biomet, Inc.

Recalled Item: Affixus Hip Fracture Nail Recalled by Zimmer Biomet, Inc. Due to During the...

The Issue: During the rework process for the April 17, 2017, field action, it was...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 7, 2017· Mako Surgical Corporation

Recalled Item: Total Hip Application (THA) Product Usage: The Robotic Arm Interactive...

The Issue: Software discrepancy of not showing all the EE constants, when the screen is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 7, 2017· Mako Surgical Corporation

Recalled Item: Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm...

The Issue: Software discrepancy of not showing all the EE constants, when the screen is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 7, 2017· Zimmer Biomet, Inc.

Recalled Item: Persona Cemented Tibial SZ PLT Size H Right Recalled by Zimmer Biomet, Inc....

The Issue: There is a potential for intermittent cracks in the raw material batch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 7, 2017· Zimmer Biomet, Inc.

Recalled Item: Persona Stemmed Tibial Provisional Size H Left Recalled by Zimmer Biomet,...

The Issue: There is a potential for intermittent cracks in the raw material batch used...

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

Class II — Potential Health HazardOngoing