Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 3721–3740 of 38,428 recalls

September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex Arterial Kit 1/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: smiths medical SurgiVet Advisor Tech Accessories

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar DPT w/Stopcock & 3cc Flush 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar Stopcock w/Ext. 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TRANSTAR MONITORING KIT 1/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar DPT w/Stopcock & 30cc Flush 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar Patient Mount Monitoring Kit 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar MONITORING SET W/SAMPLING PORT 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar DPT w/Two Stopcocks 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Medtronic Neuromodulation

Recalled Item: Medtronic Percept RC Implantable Neurostimulators (INS)

The Issue: A limited number of Percept RC Implantable Neurostimulators

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar 84in (213cm) Single Monitoring Kit 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar 60in (152cm) Single Monitoring Kit 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar Single ICP Set 1/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar Kit w/ Stopcock1/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex NICU Monitoring Kit Set 1/EA

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing
September 24, 2024· Smiths Medical ASD, Inc.

Recalled Item: medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with

The Issue: Due to a manufacturing defect, users may experience

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

Class II — Potential Health HazardOngoing