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 31501–31520 of 38,428 recalls
Recalled Item: Philips IntelliVue TcG10
The Issue: Philips has discovered that the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iPlan RT is a radiation treatment planning system that is
The Issue: iPlan RT Radiation Treatment Planning Software: Potentially incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator
The Issue: Device may malfunction, which could cause therapy to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System
The Issue: Software Anomaly: the firm has identified an anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System (VITROS 5
The Issue: Software Anomaly: the firm has identified an anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Software Anomaly: the firm has identified an anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus TAVR 23mm
The Issue: Lotus valve became unlocked during release from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus TAVR 25mm
The Issue: Lotus valve became unlocked during release from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iPlan RT Dose is a stereotactic radiation treatment planning system
The Issue: iPlan RT Radiation Treatment Planning Software: Potentially incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lotus TAVR 27mm
The Issue: Lotus valve became unlocked during release from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx
The Issue: KCI has received reports that, in a small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement LED PCB Kit
The Issue: Replacement LED Board kit of Natus neoBLUE2 Phototherapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and
The Issue: HORIBA Medical is informing all HORIBA Medical Lite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010
The Issue: Incorrect serial number of tibial inserts packaged in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Microcuff Subglottic Suctioning
The Issue: The cuff inflation line may detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Microcuff Subglottic Suctioning
The Issue: The cuff inflation line may detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Microcuff Subglottic Suctioning
The Issue: The cuff inflation line may detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Microcuff Subglottic Suctioning
The Issue: The cuff inflation line may detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KimVent Microcuff Subglottic Suctioning
The Issue: The cuff inflation line may detach from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PKG
The Issue: The parameters provided in the Laparoscopic Manual Instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.