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 2321–2340 of 38,428 recalls
Recalled Item: AirLife Product Name: AirLife Infant Heated Wire Circuit
The Issue: Adapters may disconnect during setup or while in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis HPCA Ambulatory Infusion Pump
The Issue: Affected pumps may trigger an erroneous (false) Upstream
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis VIP Ambulatory Infusion Pump
The Issue: Affected pumps may trigger an erroneous (false) Upstream
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT
The Issue: There is a potential for thermal damage in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis Infusion Pump Models: 1) PUMP KIT
The Issue: There is a potential for thermal damage in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Solis HSPCA Pump
The Issue: Pumps may experience Wireless Connection Modules intermittent connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blueprint Software
The Issue: A software bug in Blueprint version 4.2.1 prevents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Sterile Weitlaner Retractor 3 x 4 Prong
The Issue: Three is the potential for the retractors to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne Companion Diagnostic (F1CDx)
The Issue: Four (4) total reports were sent to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PiezoWave 2 Control Unit
The Issue: The high voltage capacitor may fail early in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Sterile Weitlaner Retractor
The Issue: Three is the potential for the retractors to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487
The Issue: Due to a software issue, the software may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artix MT Thrombectomy Device
The Issue: Thrombectomy device specifies vessel range of 2.5-6 mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molding Equipment. WCM series. Model WCM-330GL-i
The Issue: Apic Yamada has recently discovered that certain products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn Life2000 Compressor
The Issue: A cybersecurity vulnerability was discovered through internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn Life2000 Ventilation system
The Issue: A cybersecurity vulnerability was discovered through internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Cardiovascular software versions 6.x
The Issue: An issue was identified with the software when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as...
The Issue: Disconnection of the adapter from the endotracheal tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio 1 Granules for Filling ¿ 1 mm (2 cm¿)
The Issue: Vials of implant bone granules may contain less
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
The Issue: Incorrect labeling in which the front red pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.