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 21801–21820 of 38,428 recalls
Recalled Item: Teleflex MEDICAL WECK Visistat 35. Used for the external skin
The Issue: Some boxes are labeled as Visistat Wide devices,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS HI
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVATRON M2 / PRIMUS Mid-Energy
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Impression
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Impression Plus
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Avant-garde
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR Expression
The Issue: Control Console software has been updated to reduce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExacTrac versions 6.5 through 6.5 intended to be used to
The Issue: The usage of workflows that deviate from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold
The Issue: Tubes may exhibit stopper creepout/pullout, where the stopper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold
The Issue: Tubes may exhibit stopper creepout/pullout, where the stopper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thumper Cardiopulmonary Resuscitator
The Issue: A performance issue with the chest depth needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexLab (FLX)
The Issue: Module may freeze without generating user warning. There
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RaPET¿ RF Latex Reagent used as a component in the
The Issue: All patient serum samples yield a weakly positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK¿ PROG III
The Issue: Falsely elevated progesterone assay values will occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST AIA-PACK¿ PROG II
The Issue: Falsely elevated progesterone assay values will occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled:
The Issue: The duodenoscopes are being recalled in order to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling
The Issue: The spreader bar can detach from the scale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Connect 272 KG Scale used with Maxi Sky 2
The Issue: The spreader bar can detach from the scale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PFR Kit- Pinnacle Recalled by Boston Scientific Corporation Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capio SLIM Box 5
The Issue: for Capio sutures to break and /or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.