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 12181–12200 of 38,428 recalls
Recalled Item: Regard NEWBORN KIT
The Issue: Instructions for use updated to include the following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Suture Anchor
The Issue: Not properly sterilized, because the outer pouch seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy 100
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-Series BiPAP A 40
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics E30 with Humidifier
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SystemOne (Q-Series)
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-Series BiPAP Hybrid A30 (not marketed in US)
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DreamStation ASV
The Issue: The polyester-based polyurethane (PE-PUR) foam may degrade into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution EVO
The Issue: Improperly loaded software options may result in additional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoreValve Evolut PRO Delivery Catheter System
The Issue: Due to reports of actuator separation for various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoreValve Evolut R Delivery Catheter System
The Issue: Due to reports of actuator separation for various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoreValve Evolut PRO PLUS Delivery Catheter System
The Issue: Due to reports of actuator separation for various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arjo Citadel beds originally assembled with the IndiGo modules during
The Issue: The IndiGo power cord might wear during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for >10% under-recovery on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for 15% under-recovery on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for >10% under-recovery on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential for >10% under-recovery on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 3D Imaging
The Issue: There is a potential that the coin cell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage:
The Issue: Due to a design issue, inflation syringe handle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC Elite mobile C-arm - Product Usage: intended to provide
The Issue: There is a potential that the coin cell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.