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 8401–8420 of 38,428 recalls
Recalled Item: Ventstar Coax 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Coax 1
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (N) 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar breathing bag Set (P) 110
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Coax HEPA
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventstar Coax 230
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Bag Set (N) 110
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Watertrap (P) 180 w/oLL
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Coax (P) 150
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Coax 180
The Issue: Glued connections of the breathing circuit can become
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml
The Issue: QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro
The Issue: QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN)
The Issue: Unavailable to calibrate VITROS Chemistry Products VANC Reagent,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft
The Issue: IFU Warning: Applying bending force and/or bending force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft
The Issue: IFU Warning: Applying bending force and/or bending force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft
The Issue: IFU Warning: Applying bending force and/or bending force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft
The Issue: IFU Warning: Applying bending force and/or bending force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft
The Issue: IFU Warning: Applying bending force and/or bending force
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.