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 841–860 of 38,428 recalls

October 29, 2025· B Braun Medical Inc

Recalled Item: ULTRASITE 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: CARESAFE 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: Burette 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: 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: 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: 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: B.BRAUN 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: 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: 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: Outlook 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 28, 2025· Baxter Healthcare Corporation

Recalled Item: Welch Allyn INF BAG

The Issue: Replacement bladder kit for the Welch Allyn two-piece

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

Class II — Potential Health HazardOngoing
October 28, 2025· Illumina, Inc.

Recalled Item: Reagent Kits/ containing flow cells

The Issue: An instrument intended for sequencing DNA libraries with

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

Class II — Potential Health HazardOngoing
October 27, 2025· Medline Industries, LP

Recalled Item: Quick Strip Fabric Sterile Adhesive Bandages

The Issue: Medline has identified that all lots of the

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

Class II — Potential Health HazardOngoing