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 6161–6180 of 38,428 recalls

January 16, 2024· Avanos Medical, Inc.

Recalled Item: MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal

The Issue: MIC* Gastric - Jejunal Feeding Tube Kits contain

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

Class I — Serious Health HazardOngoing
January 16, 2024· Avanos Medical, Inc.

Recalled Item: MIC* Gastric-Jejunal Feeding Tube

The Issue: MIC* Gastric - Jejunal Feeding Tube Kits contain

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

Class I — Serious Health HazardOngoing
January 16, 2024· W&H DENTALWERK BUERMOOS GMBH

Recalled Item: W&H Surgical handpiece S-12. For Surgical treatment of dental hard

The Issue: 1:2 speed increasing surgical handpieces have been incorrectly

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

Class II — Potential Health HazardOngoing
January 16, 2024· Maquet Medical Systems USA

Recalled Item: BEQ-HLS 7050 USA

The Issue: The Emergency Priming Line, a component of the

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

Class II — Potential Health HazardOngoing
January 16, 2024· Maquet Medical Systems USA

Recalled Item: Model No. BEQ-HLS 5050 USA

The Issue: The Emergency Priming Line, a component of the

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

Class II — Potential Health HazardOngoing
January 16, 2024· Olympus Corporation of the Americas

Recalled Item: Water Filter MAJ-2318. This MAJ-2318 water filter has been designed

The Issue: Water filter may have been assembled incorrectly, resulting

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

Class II — Potential Health HazardOngoing
January 15, 2024· Medical Action Industries, Inc. 306

Recalled Item: IV Start Kit

The Issue: The kits contain saline flush syringes which were

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

Class II — Potential Health HazardOngoing
January 15, 2024· D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

Recalled Item: Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

The Issue: When using those products you may experience difficulties

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

Class II — Potential Health HazardOngoing
January 15, 2024· D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

Recalled Item: Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

The Issue: When using those products you may experience difficulties

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

Class II — Potential Health HazardOngoing
January 15, 2024· D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

Recalled Item: Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

The Issue: When using those products you may experience difficulties

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

Class II — Potential Health HazardOngoing
January 12, 2024· 3M Company - Health Care Business

Recalled Item: 3M Specialty Blade Assembly

The Issue: 3M has added the following cautionary statement regarding

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

Class II — Potential Health HazardOngoing
January 12, 2024· 3M Company - Health Care Business

Recalled Item: 3M Specialty Blade Assembly

The Issue: 3M has added the following cautionary statement regarding

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

Class II — Potential Health HazardOngoing
January 11, 2024· Micro Therapeutics, Inc.

Recalled Item: The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible

The Issue: European version of microcatheter were distributed within US

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

Class II — Potential Health HazardOngoing
January 11, 2024· Micro Therapeutics, Inc.

Recalled Item: The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible

The Issue: European version of microcatheter were distributed within US

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing
January 11, 2024· Olympus Corporation of the Americas

Recalled Item: Colonoscope

The Issue: Specific repaired colonovideoscopes were assembled without an adhesive

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

Class II — Potential Health HazardOngoing