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 4661–4680 of 38,428 recalls

June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat 60 DROP METRISET PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat 60 DROP METRISET PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L.

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Outlook OUTLOOK PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat SPACE PUMP IV SET 15D

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV 60 DROP PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat SPACE PUMP IV SET 15D

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DR PUMP SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat SPACE PUMP IV SET W/2 CARESITE

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing
June 17, 2024· B. Braun Medical, Inc.

Recalled Item: Infusomat SPACE PUMP IV SET

The Issue: for the backcheck valve to malfunction, resulting

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

Class II — Potential Health HazardOngoing