Product Recalls in Colorado

Product recalls affecting Colorado — including food, drugs, consumer products, medical devices, and vehicles distributed to Colorado. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,678 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,678 in last 12 months

Showing 95619580 of 28,964 recalls

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 3, 2021· Heartware, Inc.

Recalled Item: HeartWare HVAD Pump Implant Kit Recalled by Heartware, Inc. Due to Medtronic...

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· Axonics Modulation Technologies, Inc.

Recalled Item: BULKAMID Recalled by Axonics Modulation Technologies, Inc. Due to Lack of...

The Issue: Lack of Sterility Assurance; needle in procedure pack labeled as sterile may...

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

Class II — Potential 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· Heartware, Inc.

Recalled Item: HeartWare HVAD Pump Implant Kit Recalled by Heartware, Inc. Due to Medtronic...

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
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· Heartware, Inc.

Recalled Item: HeartWare HVAD Implant Kit Recalled by Heartware, Inc. Due to Medtronic is...

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· Heartware, Inc.

Recalled Item: HeartWare HVAD Pump Implant Kit Recalled by Heartware, Inc. Due to Medtronic...

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· Heartware, Inc.

Recalled Item: HeartWare HVAD Outflow Graft Recalled by Heartware, Inc. Due to Medtronic is...

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· Heartware, Inc.

Recalled Item: HeartWare HVAD Pump Implant Kit Recalled by Heartware, Inc. Due to Medtronic...

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· Heartware, Inc.

Recalled Item: HeartWare HVAD Implant Kit Recalled by Heartware, Inc. Due to Medtronic is...

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· Heartware, Inc.

Recalled Item: HeartWare HVAD Pump Accessories Recalled by Heartware, Inc. Due to Medtronic...

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 2, 2021· Mckesson Medical-Surgical Inc. Corporate Office

Recalled Item: ANCILLARY ADULT 140-DOSE CONVENIENCE KIT Recalled by Mckesson...

The Issue: Two unsuitable 3mL syringes with conventional needles for vaccine...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System Standard Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 2, 2021· Biomet, Inc.

Recalled Item: Arcos Modular Revision Hip System High Offset Cone Prox Body Recalled by...

The Issue: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner...

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

Class II — Potential Health HazardOngoing