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 16881–16900 of 38,428 recalls
Recalled Item: Toco+ transducer with ECG/IUP capability (wired)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Button-Style Tocotransducer (Nautilus)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound Transducer (M2736A)
The Issue: Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-O
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics V680 Ventilator
The Issue: Ventilator touchscreen may become frozen and fail to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNI Hip System Model
The Issue: Stems missing porous coating on the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 -
The Issue: Due to low Quality Control recovery and invalid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product
The Issue: Due to low Quality Control recovery and invalid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication
The Issue: The firm received a report of an atypical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED
The Issue: Affected devices contain a Printed Circuit Assembly (PCA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart FRx AED
The Issue: Affected devices contain a Printed Circuit Assembly (PCA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS chemistry Products Cl- Slides
The Issue: Users may experience intermittent slide dispense issues with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS chemistry Products K+ Slides
The Issue: Users may experience intermittent slide dispense issues with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rosa Brain 3.0
The Issue: The instrument holder may be sent on a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS chemistry Products Cl- Slides
The Issue: Users may experience intermittent slide dispense issues with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For
The Issue: Some Thorecon disposable tensioners supplied in different Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For
The Issue: Some Thorecon disposable tensioners supplied in different Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For
The Issue: Some Thorecon disposable tensioners supplied in different Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For
The Issue: Some Thorecon disposable tensioners supplied in different Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For
The Issue: Some Thorecon disposable tensioners supplied in different Plating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canister HFC-134a /1000g
The Issue: The canister neck bushing may become loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.