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. 2,526 recalls have been distributed to Montana in the last 12 months.

48,326 total recalls
2,526 in last 12 months

Showing 93419360 of 27,852 recalls

Medical DeviceJune 10, 2021· Merit Medical Systems, Inc.

Recalled Item: basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Recalled by...

The Issue: Due to a design issue, inflation syringe handle separating from the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 10, 2021· GE OEC Medical Systems, Inc

Recalled Item: OEC Elite mobile C-arm - Product Usage: intended to provide Recalled by GE...

The Issue: There is a potential that the coin cell battery used to monitor X-Ray tube...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 10, 2021· Mercedes Medical, Inc.

Recalled Item: Lingen SAMPLE Disposable Virus Sampling Kit pack Recalled by Mercedes...

The Issue: No 510(k) clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 10, 2021· Mercedes Medical, Inc.

Recalled Item: Lingen Disposable Virus Sampling Kit Recalled by Mercedes Medical, Inc. Due...

The Issue: No 510(k) clearance

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2021· Olympus Corporation of the Americas

Recalled Item: Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation...

The Issue: Expired adhesive used as an electrical insulation barrier and as a secondary...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2021· Cardinal Health 200, LLC

Recalled Item: Infant Heel Warmer with Attachment Tab Recalled by Cardinal Health 200, LLC...

The Issue: A caution statement is being added to remind the user to activate away from...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2021· Cardinal Health 200, LLC

Recalled Item: Infant Heel Warmer without Attachment Tab Recalled by Cardinal Health 200,...

The Issue: A caution statement is being added to remind the user to activate away from...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 9, 2021· Cordis Corporation

Recalled Item: Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for...

The Issue: The product in the packaging is larger (both inner and outer diameter) than...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2021· Philips North America Llc

Recalled Item: 728333 Spectral CT 7500 -Computed Tomography X-ray system Recalled by...

The Issue: When setting patient weight unit preferences to pounds, SynchRight P3T...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2021· Philips North America Llc

Recalled Item: 728332 IQon Spectral CT-Computed Tomography X-ray system Recalled by Philips...

The Issue: When setting patient weight unit preferences to pounds, SynchRight P3T...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2021· Philips North America Llc

Recalled Item: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system Recalled by...

The Issue: When setting patient weight unit preferences to pounds, SynchRight P3T...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2021· Philips North America Llc

Recalled Item: 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance...

The Issue: When setting patient weight unit preferences to pounds, SynchRight P3T...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 8, 2021· Philips North America Llc

Recalled Item: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography...

The Issue: When setting patient weight unit preferences to pounds, SynchRight P3T...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 7, 2021· BioFire Diagnostics, LLC

Recalled Item: FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 /...

The Issue: Due to real-time stability study failures resulting in increase rate of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 7, 2021· BioFire Diagnostics, LLC

Recalled Item: FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No:...

The Issue: Due to real-time stability study failures resulting in increase rate of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2021· Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Recalled Item: Simpleware ScanIP software. For transfer of imaging information from a...

The Issue: A issue (bug) has been identified with the interface and image software...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2021· Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Recalled Item: Simpleware ScanIP medical software. For transfer of imaging information from...

The Issue: A issue (bug) has been identified with the interface and image software...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2021· Eight Medical International BV

Recalled Item: Recirculator 8.0s Disposable Lavage Kit (product code number 8100) Recalled...

The Issue: The patient may be exposed to potential aluminum ion release during warming...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 3, 2021· Heartware, Inc.

Recalled Item: HeartWare HVAD Driveline Extension Cable Recalled by Heartware, Inc. Due to...

The Issue: Medtronic is stopping the distribution and sale of the HVAD System due to a...

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

Class I — Serious Health HazardOngoing
Medical DeviceJune 3, 2021· Ethicon Endo-Surgery Inc

Recalled Item: ECHELON FLEX Powered Plus Stapler-intended for transection Recalled by...

The Issue: Mislabeled: Labeled on the package as 60mm contains 45mm devices

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

Class II — Potential Health HazardOngoing