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. 2,344 recalls have been distributed to Maine in the last 12 months.

48,770 total recalls
2,344 in last 12 months

Showing 3448134500 of 48,770 recalls

Medical DeviceDecember 21, 2015· Therakos Inc

Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...

The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· ConMed Corporation

Recalled Item: Hip Preservation System Signature Series PreBent Burs under the following...

The Issue: Metal shavings released from burs during use are due to contact between the...

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

Class II — Potential Health HazardOngoing
DrugDecember 21, 2015· Teva North America

Recalled Item: Capecitabine tablets USP 500 mg Recalled by Teva North America Due to Failed...

The Issue: Failed Dissolution Specifications: low test results at the 18 month time-point

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 21, 2015· Noven Pharmaceuticals, Inc.

Recalled Item: Daytrana (methylphenidate transdermal system) Transdermal Patch Recalled by...

The Issue: Defective Delivery System: Out of Specification (OOS) results for the...

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 21, 2015· Noven Pharmaceuticals, Inc.

Recalled Item: Daytrana (methylphenidate transdermal system) Transdermal Patch Recalled by...

The Issue: Defective Delivery System: Out of Specification (OOS) results for the...

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 21, 2015· Noven Pharmaceuticals, Inc.

Recalled Item: Daytrana (methylphenidate transdermal system) Transdermal Patch Recalled by...

The Issue: Defective Delivery System: Out of Specification (OOS) results for the...

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 18, 2015· National Vitamin Co Inc

Recalled Item: Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each Recalled...

The Issue: Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as...

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

Class III — Low RiskOngoing
Refund
Medical DeviceDecember 18, 2015· GE Medical Systems, LLC

Recalled Item: Mavig Monitor Suspension System Recalled by GE Medical Systems, LLC Due to...

The Issue: GE Healthcare has recently become aware of a reported incident in which a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· NeoCoil, LLC

Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC...

The Issue: Potential for higher than specified surface temperatures. Use of 3.0T GEM...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Stryker Spine

Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...

The Issue: Reported jamming of the impaction handle when assembled to the Inserter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· EndoChoice, Inc.

Recalled Item: Fuse 1C Colonoscope Recalled by EndoChoice, Inc. Due to The bending section...

The Issue: The bending section of the device may partially separate from the insertion...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Elekta, Inc.

Recalled Item: Oncentra External Beam - VMAT - Radiation therapy planning system Recalled...

The Issue: When using the option "Tumor Overlap Fraction" in VMAT planning it has been...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Recalled by C.R. Bard,...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter Recalled by C.R....

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Arthrex, Inc.

Recalled Item: Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC Recalled by...

The Issue: Devices reported to have a smooth texture to the outer surface of the metal,...

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

Class II — Potential Health HazardOngoing
DrugDecember 17, 2015· Virtus Pharmaceuticals, Llc

Recalled Item: VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary...

The Issue: Defective Delivery System: Product may contain leaking capsules.

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

Class III — Low RiskOngoing
Refund
DrugDecember 17, 2015· Bio-pharm, Inc.

Recalled Item: Ranitidine Syrup (Ranitidine Oral Solution Recalled by Bio-pharm, Inc. Due...

The Issue: Failed Impurities/Degradation Specifications: Product recalled due to...

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

Class III — Low RiskOngoing
Refund
Medical DeviceDecember 17, 2015· Merge Healthcare, Inc.

Recalled Item: RadSuite Recalled by Merge Healthcare, Inc. Due to Potential incorrect...

The Issue: Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.

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

Class II — Potential Health HazardOngoing