Product Recalls in Montana

Product recalls affecting Montana — including food, drugs, consumer products, medical devices, and vehicles distributed to Montana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,466 recalls have been distributed to Montana in the last 12 months.

48,326 total recalls
2,466 in last 12 months

Showing 1622116240 of 48,326 recalls

Medical DeviceDecember 14, 2020· Prytime Medical Devices, Inc.

Recalled Item: PRYTIME MEDICAL REBOA Catheter Introducer Kit Recalled by Prytime Medical...

The Issue: There is a potential that a catheter convenience set contains a 21G access...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 14, 2020· Phadia US Inc

Recalled Item: EliA dsDNA Well - Product Usage: intended for the In-Vitro Recalled by...

The Issue: Decreased values for EliA ANA Positive Control when using the EliA dsDNA...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 14, 2020· Brainreader ApS

Recalled Item: Neuroreader Medical Image Processing Software - Product Usage: intended to...

The Issue: The Neuroreader has been distributed with a normative database that is...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 14, 2020· K2M, Inc

Recalled Item: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026) Recalled by...

The Issue: The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 14, 2020· Integra LifeSciences Corp.

Recalled Item: Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage:...

The Issue: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 14, 2020· Integra LifeSciences Corp.

Recalled Item: Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use...

The Issue: Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2020· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Recalled...

The Issue: The software does not update measurements and calculations in the Clinical...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2020· Steris Corporation

Recalled Item: Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended...

The Issue: The electrical contactor component present in the drying chamber of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2020· Baxter Healthcare Corporation

Recalled Item: VERITAS Collagen Matrix - Product Usage: intended for use in Recalled by...

The Issue: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2020· Ortho Clinical Diagnostics Inc

Recalled Item: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide...

The Issue: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results...

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

Class II — Potential Health HazardOngoing
DrugDecember 10, 2020· Fresenius Kabi USA, LLC

Recalled Item: Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection Recalled by...

The Issue: Subpotent Drug: Low out-of-specification assay results for the epinephrine...

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

Class II — Potential Health HazardOngoing
Refund
Medical DeviceDecember 10, 2020· GE Healthcare, LLC

Recalled Item: GE Healthcare Precision 600FP Recalled by GE Healthcare, LLC Due to GE...

The Issue: GE Healthcare has become aware of a potential safety issue associated with...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 10, 2020· Clerio Vision

Recalled Item: Clerio Vision Recalled by Clerio Vision Due to One lot of contact lenses...

The Issue: One lot of contact lenses labeled as BC MED, DIA 14.0 PWR -2.25 contained BC...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 10, 2020· Accuray Incorporated

Recalled Item: TomoTherapy Treatment Delivery System with iDMS - Product Usage: used...

The Issue: "MLC tickle error" may result in the delivered dose to effectively rotate...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 10, 2020· Accuray Incorporated

Recalled Item: TomoTherapy Treatment System - Product Usage: used as an integrated Recalled...

The Issue: "MLC tickle error" may result in the delivered dose to effectively rotate...

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

Class II — Potential Health HazardOngoing
DrugDecember 9, 2020· Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Recalled Item: Auryxia (ferric citrate) tablets Recalled by Akebia Therapeutics dba Keryx...

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 9, 2020· Morton Grove Pharmaceuticals, Inc.

Recalled Item: Hydroxyzine Hydrochloride Oral Solution Recalled by Morton Grove...

The Issue: Failed Impurities/Degradation Specification: OOS for the following - unknown...

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 9, 2020· Biogen MA Inc.

Recalled Item: Vumerity (diroximel fumarate) delayed-release capsule Recalled by Biogen MA...

The Issue: Failed dissolution specifications: out-of-specification test results...

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 8, 2020· Shilpa Medicare Limited

Recalled Item: Azacitidine for Injection 100 mg/vial Recalled by Shilpa Medicare Limited...

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund
DrugDecember 8, 2020· Shilpa Medicare Limited

Recalled Item: Imatinib Mesylate Tablets 400 mg Recalled by Shilpa Medicare Limited Due to...

The Issue: CGMP Deviations

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

Class II — Potential Health HazardOngoing
Refund