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 741–760 of 38,428 recalls

October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· Philips North America Llc

Recalled Item: CT 5300

The Issue: If the screws of tube heat exchanger on

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

Class II — Potential Health HazardOngoing
October 29, 2025· Philips North America Llc

Recalled Item: Incisive CT

The Issue: If the screws of tube heat exchanger on

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

Class II — Potential Health HazardOngoing
October 29, 2025· Medtronic, Inc.

Recalled Item: Aurora EV-ICD and Clinical EV-ICD

The Issue: There is a potential for delayed time to

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Blood Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Blood Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: SafeDAY set utilized in gravity IV administration sets and pump

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Anesthesia IV Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Infusomat utilized in gravity IV administration sets and pump administration

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Extension Set utilized in gravity IV administration sets and pump

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: IV Administration Set utilized in gravity IV administration sets and

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing
October 29, 2025· B Braun Medical Inc

Recalled Item: Extension Set utilized in gravity IV administration sets and pump

The Issue: for backflow of medication from secondary (piggyback)

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

Class II — Potential Health HazardOngoing