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 3641–3660 of 38,428 recalls

October 7, 2024· Philips Respironics, Inc.

Recalled Item: Trilogy Evo O2. Model Numbers: FP2100X10

The Issue: for in-line nebulizer configuration in certain locations

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

Class I — Serious Health HazardOngoing
October 7, 2024· Philips Respironics, Inc.

Recalled Item: Trilogy Evo. Model Numbers: DS2110X11B

The Issue: for in-line nebulizer configuration in certain locations

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

Class I — Serious Health HazardOngoing
October 7, 2024· PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Recalled Item: Philips Zenition 70

The Issue: for the Mains Control Unit board fuse

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

Class II — Potential Health HazardOngoing
October 5, 2024· St. Jude Medical

Recalled Item: CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial...

The Issue: As a result of a cloud data migration

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

Class II — Potential Health HazardOngoing
October 5, 2024· St. Jude Medical

Recalled Item: CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient...

The Issue: As a result of a cloud data migration

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Caire, Inc.

Recalled Item: CAIRE FreeStyle Comfort portable oxygen concentrator

The Issue: failure of affected units to recharge the

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

Class II — Potential Health HazardCompleted
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Caire, Inc.

Recalled Item: CAIRE FreeStyle Comfort portable oxygen concentrator

The Issue: failure of affected units to recharge the

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

Class II — Potential Health HazardCompleted
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Caire, Inc.

Recalled Item: CAIRE FreeStyle Comfort portable oxygen concentrator

The Issue: failure of affected units to recharge the

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

Class II — Potential Health HazardCompleted
October 4, 2024· Caire, Inc.

Recalled Item: CAIRE FreeStyle Comfort portable oxygen concentrator

The Issue: failure of affected units to recharge the

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

Class II — Potential Health HazardCompleted
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Hobbs Medical, Inc.

Recalled Item: Posi-Stop Injection Needle

The Issue: Injection solutions would not flow as intended through

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

Class II — Potential Health HazardOngoing
October 4, 2024· Stryker Corporation

Recalled Item: Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil

The Issue: There is a potential for the product to

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

Class II — Potential Health HazardOngoing
October 4, 2024· Stryker Corporation

Recalled Item: Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm

The Issue: There is a potential for the product to

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

Class II — Potential Health HazardOngoing