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.
Showing 2921–2940 of 38,428 recalls
Recalled Item: RayStation Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation -Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation- Intended as a Radiation Therapy Treatment Planning
The Issue: Inconsistency in the use of Density uncertainty in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX400. Model Number: 866060
The Issue: failure to alarm for "No Device Data"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device
The Issue: Error in the IFU lists an incorrect incubation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal AMG Suction Connector Tubing
The Issue: The tubing may not ensure that the yankauer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Single Use Guide Sheath Kits with the following product
The Issue: for the radiopaque tip of the guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System
The Issue: Image offsets calculated by oncology Information System software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vaporizer Sevoflurane
The Issue: Sevoflurane used with the vaporizer may degrade to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sertera Biopsy Device Product Name: Sertera Biopsy Device
The Issue: Devices presented a condition in which the inner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX450. Model Number: 866062
The Issue: failure to alarm for "No Device Data"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX550. Model Number: 866066
The Issue: failure to alarm for "No Device Data"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor MX500. Model Number: 866064
The Issue: failure to alarm for "No Device Data"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliBridge EC10 Module. Model Number: 865115
The Issue: failure to alarm for "No Device Data"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Central Station. Model Number: MS26800 The Infinity CentralStation...
The Issue: Edifier speakers (shipped in or after April 2023)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 B20
The Issue: Possibility of the patient falling from the table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 B12
The Issue: Possibility of the patient falling from the table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.