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. 2,548 recalls have been distributed to Montana in the last 12 months.

48,326 total recalls
2,548 in last 12 months

Showing 50815100 of 27,852 recalls

Medical DeviceNovember 28, 2023· AtriCure, Inc.

Recalled Item: Cryo Module Accessories Domestic CMA-OUS Recalled by AtriCure, Inc. Due to...

The Issue: AtriCure has identified certain lots of tank hose assemblies where a...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Philips North America

Recalled Item: (1) Patient Information Center iX Recalled by Philips North America Due to...

The Issue: Push notifications may fail to send to the user under certain conditions....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Philips North America

Recalled Item: (1) CareEvent Recalled by Philips North America Due to Push notifications...

The Issue: Push notifications may fail to send to the user under certain conditions....

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Medtronic Navigation, Inc.

Recalled Item: Medtronic Recalled by Medtronic Navigation, Inc. Due to Their is the...

The Issue: Their is the potential that the percutaneous pin may have a cross-pin that...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Medtronic Navigation, Inc.

Recalled Item: Medtronic Recalled by Medtronic Navigation, Inc. Due to Their is the...

The Issue: Their is the potential that the percutaneous pin may have a cross-pin that...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Natus Medical Incorporated

Recalled Item: EDS 3 CSF External Drainage System Recalled by Natus Medical Incorporated...

The Issue: Sterility assurance cannot be guaranteed for external drainage systems due...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 28, 2023· Natus Medical Incorporated

Recalled Item: External Drainage System Collection Bag Recalled by Natus Medical...

The Issue: Sterility assurance cannot be guaranteed for external drainage systems due...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Mirion Technologies (Capintec), Inc.

Recalled Item: Captus 4000e Thyroid Uptake Systems- Intended to be used by Recalled by...

The Issue: Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack Recalled...

The Issue: Affected lots may experience increased calibration failures or an increase...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Philips Respironics, Inc.

Recalled Item: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B...

The Issue: The following was missing from the Contraindications Statement: The AVAPS-AE...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 27, 2023· Acumed LLC

Recalled Item: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY Recalled by Acumed LLC Due to...

The Issue: Due to potential breakage during use.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 23, 2023· FUJIFILM Healthcare Americas Corporation

Recalled Item: The device is a mobile x-ray system designed to work Recalled by FUJIFILM...

The Issue: When the key switch is turned on, the exposure conditions are set to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 23, 2023· ACTIM OY

Recalled Item: Actim PROM dipstik Recalled by ACTIM OY Due to Interference testing has...

The Issue: Interference testing has shown that the presence of personal lubricants in...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 21, 2023· Beckman Coulter, Inc.

Recalled Item: Access Ultrasensitive Insulin only used on the DxI 9000 Access Recalled by...

The Issue: There is an issue with the Access Ultrasensitive Insulin assay protocol file...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 21, 2023· Beckman Coulter, Inc.

Recalled Item: DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior...

The Issue: There are potential performance issues found in the DxI 9000 Access...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· LEICA BIOSYSTEMS NUSSLOCH GMBH

Recalled Item: Leica HistoCore PEGASUS (PROCESSOR Recalled by LEICA BIOSYSTEMS NUSSLOCH...

The Issue: There is an issue regarding poorly processed and/or damaged biopsy tissue...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Randox Laboratories Ltd.

Recalled Item: Calibration Serum Level 3 - IVD For use as a Recalled by Randox Laboratories...

The Issue: Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Randox Laboratories Ltd.

Recalled Item: Calibration Serum Level 3 CAL2351 Recalled by Randox Laboratories Ltd. Due...

The Issue: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Olympus Corporation of the Americas

Recalled Item: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model:...

The Issue: Instructions for Use-User Deviations related to the reprocessing of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 20, 2023· Medtronic Inc.

Recalled Item: Protege GPS Self-Expanding Peripheral Stent System Recalled by Medtronic...

The Issue: Seal defects could compromise the ability of the product packaging to...

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

Class II — Potential Health HazardOngoing