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 31481–31500 of 38,428 recalls
Recalled Item: Phadia 1000 Instrument (introduced as UniCAP 1000)
The Issue: During an investigation of instrument logs it was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage:
The Issue: Roche Diabetes Care was informed by UnoMedical, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniStrip1
The Issue: Failure to submit a 510(k) for device labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyberonics VNS Therapy AspireHC
The Issue: The recalled product was distributed with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaMap Orion High Resolution Mapping Catheter
The Issue: Some IntellaMap Orion High Resolution Mapping Catheters are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECG Out Cable
The Issue: When a Philips monitor/defibrillator is receiving an ECG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator Models:M3535A
The Issue: MRx Defib can be susceptible to one or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
The Issue: 1. Device will perform the weekly automated tests
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE MV System
The Issue: There may be an existing dark current phenomenon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.