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 12281–12300 of 38,428 recalls

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

Recalled Item: ANCILLARY ADULT 140-DOSE CONVENIENCE KIT

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

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

Class II — Potential Health HazardTerminated
June 1, 2021· Integra LifeSciences Corp.

Recalled Item: CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide...

The Issue: Packaging-pouches with wrinkles across the Tyvek side may

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

Class II — Potential Health HazardTerminated
June 1, 2021· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Medtronic Reveal LINQ LNQ11 / PA96000

The Issue: Reveal LINQ with TruRhythm ICMs, that undergo a

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

Class II — Potential Health HazardOngoing
June 1, 2021· Ossur Americas

Recalled Item: OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended

The Issue: Due to insufficient column strength of the racks

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

Class II — Potential Health HazardTerminated
May 28, 2021· Southwest Technologies Inc

Recalled Item: Stimulen Collagen Moisturizing Lotion

The Issue: Dose audit failure after sterilization process

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Repair Kit 15 FR TAL 55cm

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Repair Kit 15 FR TAL 23cm

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Repair Kit 15 FR TAL 44cm

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Repair Kit 15 FR TAL 33cm

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Repair Kit 15 FR TAL 19cm

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing
May 28, 2021· Covidien, LP

Recalled Item: Palindrome RT Chronic Catheter Kit Symmetrical Tip

The Issue: This voluntary withdrawal is being conducted to implement

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

Class II — Potential Health HazardOngoing