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 18161–18180 of 38,428 recalls

April 17, 2019· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero...

The Issue: Updated Warning Statements in the Operator's Manual/Directions for

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

Class II — Potential Health HazardTerminated
April 17, 2019· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero...

The Issue: Updated Warning Statements in the Operator's Manual/Directions for

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

Class II — Potential Health HazardTerminated
April 17, 2019· Angiodynamics Inc. (Navilyst Medical Inc.)

Recalled Item: AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero...

The Issue: Updated Warning Statements in the Operator's Manual/Directions for

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/o Ind

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 17, 2019· Remel Inc

Recalled Item: Thio Med w/Dex

The Issue: for products to fail performance testing per

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

Class II — Potential Health HazardTerminated
April 16, 2019· Ad-Tech Medical Instrument Corporation

Recalled Item: AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth

The Issue: An Ad-Tech Clinical Specialist, attended a case on

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

Class II — Potential Health HazardTerminated
April 16, 2019· OCULOGICA

Recalled Item: EyeBOX Model OCL 02

The Issue: A review of the user manual revealed that

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

Class II — Potential Health HazardTerminated
April 16, 2019· Zimmer Surgical Inc

Recalled Item: Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated