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 17161–17180 of 38,428 recalls
Recalled Item: da Vinci SP Surgical System
The Issue: The firm become aware of a potentially defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed Carestation CS1 - Product Usage: The device can
The Issue: Fasteners potentially torqued to a value less than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing
The Issue: An anomaly is present in InoqulA / InoqulA+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing...
The Issue: An anomaly is present in InoqulA / InoqulA+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Urinalysis Control Level 2 (IVD) - Product
The Issue: Analyte range for Leukocytes for use with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed...
The Issue: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrig ETF Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Push Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endintrak 2 Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Triangle Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endintrak¿ 2 Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Triangle Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Push Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Triangle Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Hook Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Triangle Blade
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WS80A Diagnostic Ultrasound System Version 1.00.16
The Issue: There is a potential for probes overheating when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.