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 22941–22960 of 38,428 recalls
Recalled Item: Carl Zeiss INTRABEAM PRS 500
The Issue: The device had an incorrect printed calibration value
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13
The Issue: A limited portion of the lot was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Partial Knee System Product Usage: The Persona Partial Knee
The Issue: for the Persona Partial Knee Impactor Pad
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assurity MRI Model Numbers: PM1272
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PM1214 NUANCE SR RF
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assurity Model Numbers: PM1240
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models...
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anthem Model Numbers: PM3210
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PM 1250 and PM 2250 ZENEX
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PM 1260 ASSURITY + These low voltage (LV) devices are
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low
The Issue: New pacemaker firmware was developed to further mitigate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q
The Issue: The device may exhibit premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unify
The Issue: The device may exhibit premature battery depletion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for
The Issue: The affected products are labeled and etched as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGC 2000 LP Patella
The Issue: The affected AGC 2000 LP Patella products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGC 2000 LP Patella
The Issue: The affected AGC 2000 LP Patella products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK(R) 2 GP
The Issue: Customer reports have indicated occurrences of atypical negative
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.