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 12921–12940 of 38,428 recalls
Recalled Item: 30" (76 cm) Appx 3.3 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Appx 1.0 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 30" (76 cm) Appx 4.1 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinning Spiros Closed Male Luer
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinning Spiros Closed Male Luer - Product Usage:
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5" (13 cm) Appx 0.50 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 45" (114 cm) Appx 1.7 ml
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spiros Closed Male Luer - Product Usage: provides
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Admin Set w/ClaveTM
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20mL Syringe w/Spinning Spiros
The Issue: Due to molding defect, there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Abre Venous Self-expanding Sent System
The Issue: Incorrect size printed on the device; packaging is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Controller - Product Usage: intended for use with a
The Issue: May have been programmed with a less than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS¿ CMV IgM 30 Tests
The Issue: bioMerieux received complaints about calibration issue observed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct...
The Issue: Interference condition between the 10mm Drill Guide Inserter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN
The Issue: Due to a software design issue, under certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL
The Issue: Due to a software design issue, under certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDURITY Pulse Generator **** SN ********* St. Jude Medical
The Issue: Due to a manufacturing issue associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASSURITY Pulse Generator **** SN ********* ST. JUDE MEDICAL
The Issue: Due to a manufacturing issue associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Filtered Triple-Leg Extension Set - Intravascular administration set....
The Issue: BBMI has identified through complaints the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.