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 20141–20160 of 38,428 recalls
Recalled Item: ADVIA Centaur CKMB Master Curve Material
The Issue: A potential bias was identified with certain kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CKMB Calibrator 2-pack Japan
The Issue: A potential bias was identified with certain kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE
The Issue: BioFlo Ports was partially manufactured with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostica Stago STA N¿oplastine¿ CI
The Issue: QC values outside of the assigned ranges (prolonged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostica Stago STA N¿oplastine¿ CI Plus
The Issue: QC values outside of the assigned ranges (prolonged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Carestation 620/650/650c
The Issue: On systems equipped with the Auxiliary Common Gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Mako Vizadisc Knee Procedure Tracking Kit
The Issue: Specific lots of the Vizadisc Knee Procedure Tracking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Carestation 30 anesthesia systems
The Issue: On systems equipped with the Auxiliary Common Gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE 9100c NXT anesthesia systems
The Issue: On systems equipped with the Auxiliary Common Gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Mako Vizadisc Hip Procedure Tracking Kit
The Issue: Specific lots of the Vizadisc Knee Procedure Tracking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ1 Advanced XL
The Issue: An issue with the power branching printed circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Durex Real Feel Polyisoprene Condoms
The Issue: The products failed the filed specification of 1.0kPa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freedom EV0-2 with any version of EVOware and EVOware Sample
The Issue: There is a software issue that can potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear
The Issue: Johnson and Johnson Vision Care received a number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CE17TKFSDTD EPID TRAY W/17GA FIXED WING
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CNB200TKU NON-STIM CATH FULL KIT
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CNBFX350O CONTIPLEX CONT NERVE BLOCK
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CE17TKPS CONTINUOUS EPIDURAL ANES TRAY
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CE17TKCD CONT EPIDURAL ANESTHESIA KIT
The Issue: The catheter connectors may not stay closed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.