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 26061–26080 of 38,428 recalls
Recalled Item: ANGIODYNAMICS 4F Stiffened Micro-Introducer
The Issue: Greatbatch Medical the manufacturer of the 4F and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V6 Rear Case Assembly
The Issue: A correction was issued for the SIGMA Spectrum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library
The Issue: A correction was issued for the SIGMA Spectrum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library
The Issue: A correction was issued for the SIGMA Spectrum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
The Issue: Complaints have been reported that the handpiece is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOTECH Endoscope Cleaner and Reprocessor System 208V
The Issue: Advanced Sterilization Products (ASP) is recalling the EVOTECH
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSPAC¿ IV MONITORING KIT
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TP4 Monitoring Kit w/84" Safeset" Reservoir
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac¿ IV Monitoring Kit w/Safeset" Blood Sampling Port and 03
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CATH LAB KIT
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transpac¿ IV Bifurcated Monitoring Kit w/03 ml Squeeze Flush Device
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSPAC¿ IV MONITORING KIT NEONATAL
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP.
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSPAC¿ IV MONITORING KIT
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSPAC¿ IV MONITORING KIT
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.