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. 2,530 recalls have been distributed to Montana in the last 12 months.

48,326 total recalls
2,530 in last 12 months

Showing 92419260 of 27,852 recalls

Medical DeviceJuly 9, 2021· Ortho8, Inc.

Recalled Item: EVEXIA LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to EVEXIA...

The Issue: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Argon Medical Devices, Inc

Recalled Item: Scorpion Portal Vein Access Set - Product Usage: used to Recalled by Argon...

The Issue: As a result of design changes, sheaths have exhibited cracking/breaking at...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Carl Zeiss Meditec, Inc.

Recalled Item: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX Recalled...

The Issue: Due to failure to acquire pre-market clearance for its high resolution...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2021· Sunrise Medical (US) LLC

Recalled Item: Zippie Voyage Recalled by Sunrise Medical (US) LLC Due to The seating system...

The Issue: The seating system unexpectedly detached, which resulted in the seating...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 7, 2021· Baxter Healthcare Corporation

Recalled Item: Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recalled by...

The Issue: Software issue: The defect creates a mismatch between linked drug...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit ()- Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Siemens Healthcare Diagnostics, Inc

Recalled Item: Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in Recalled by Siemens...

The Issue: Product does not meet the Instructions for Use (IFU) claimed Pack...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 6, 2021· Advance Dx, Inc.

Recalled Item: Advance Dx 100 Blood Collection Card Quantity 25 Recalled by Advance Dx,...

The Issue: Due to high glucose test results when using the blood collection cards.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 2, 2021· Hero Health

Recalled Item: The Hero Model 100 (H-100) is a system consisting of Recalled by Hero Health...

The Issue: Due to dispenser prompting for a missed dose that had already been dispensed

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Howmedica Osteonics Corp.

Recalled Item: Triathlon Prim CEM FXD BPLT 7 Recalled by Howmedica Osteonics Corp. Due to...

The Issue: The internal profile of the Triathlon Prim (Baseplate) is potentially...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Arthroscopy Kit Recalled by Medline Industries Inc Due to The kits...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 ANTIGEN QC Recalled by Beckman Coulter Inc. Due to...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION Recalled by Beckman Coulter...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Knee Arthroscopy Kit Recalled by Medline Industries Inc Due to The...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: ACCESS SARS-CoV-2 Antigen Recalled by Beckman Coulter Inc. Due to SARS-CoV-2...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Total Knee Recalled by Medline Industries Inc Due to The kits may...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Medline Industries Inc

Recalled Item: Medline Shoulder CDS convenience kits Recalled by Medline Industries Inc Due...

The Issue: The kits may contain an expired component.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 1, 2021· Beckman Coulter Inc.

Recalled Item: Access SARS-CoV-2 Antigen Calibrators Recalled by Beckman Coulter Inc. Due...

The Issue: SARS-CoV-2 Antigen Assay test may generate false positive results which...

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

Class II — Potential Health HazardOngoing