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 7001–7020 of 38,428 recalls
Recalled Item: TruWave Pressure monitoring set
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FloTrac Sensor
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruWave with Vamp System Pressure monitoring set
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FloTrac Sensor with Vamp System
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acumen IQ Sensor
The Issue: Their is the potential for flushing difficulties during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper IGTS Fixed Systems
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIRST RESPONSE 2 CT
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BV Endura
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARC TEETH WHITENING PEN 0.06 FL OZ
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORAL B MOUTH SORE RINSE 237ML
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veradius Unity Mobile Surgery C-arm
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion IGTS Fixed Systems
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS Patient Electronic System (PES)
The Issue: for damaged and frayed power connector plug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GOODSENSE DENTURE CLEANSER GRN TAB 40CT
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenition 50 & 70 Mobile Surgery C-arm
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AT HOME MARIJUANA TEST STRIP
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIXODENT ORG CREAM 2.4OZ
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integris-Allura IGTS Fixed Systems
The Issue: Philips has become aware of an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.