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 5641–5660 of 38,428 recalls

March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· Boston Scientific Corporation

Recalled Item: Expo 5F Selective Angiographic Catheters

The Issue: An increase in complaints related to an inability

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

Class I — Serious Health HazardOngoing
March 21, 2024· SonarMed Inc

Recalled Item: AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed

The Issue: The failure to detect the partial obstruction in

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

Class I — Serious Health HazardOngoing
March 21, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models:...

The Issue: Coolant level in the cooling circuit drops below

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

Class II — Potential Health HazardOngoing
March 20, 2024· Ontact Inc

Recalled Item: 24K Premium Lense

The Issue: Contact lenses recalled due to potential bacterial contamination

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

Class II — Potential Health HazardOngoing
March 20, 2024· Baxter Healthcare Corporation

Recalled Item: Baxter Spectrum IQ Infusion Pump

The Issue: One device was improperly performed testing prior to

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing
March 20, 2024· Zimmer, Inc.

Recalled Item: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate

The Issue: Thread form issue for the locking holes in

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

Class II — Potential Health HazardOngoing