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 21601–21620 of 38,428 recalls
Recalled Item: Vascular Solutions Venture Rx Catheter
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial...
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Optisite Arterial Perfusion Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Femoral Venous Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci X Surgical System
The Issue: Specific da Vinci X Surgical Systems (IS4200) were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product
The Issue: Recalling firm was informed that as a result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3)
The Issue: Products labeled for distribution outside the United States
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-RAD Self-Tapping Locking Screw intended for the fixation of fractures
The Issue: One lot of D-RAD Self-Taping Locking Screws used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps
The Issue: Incorrect gel part number listed in a master
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part no. 690.379
The Issue: Affected screw gauges incorrectly measure screws 5.41mm shorter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part no. 690.380
The Issue: Affected screw gauges incorrectly measure screws 5.41mm shorter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Part no. 690.375
The Issue: Affected screw gauges incorrectly measure screws 5.41mm shorter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK Testosterone
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK Cort
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK Prolactin
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK FSH
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK CA 19-9
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK Fer
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST-AIA PACK ¿HCG
The Issue: Asfotase Alfa (Strensiq) interferes with certain Tosoh assays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.