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 6041–6060 of 38,428 recalls
Recalled Item: SPII Model Lubinus
The Issue: Due to two complaints, has come to our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X3 TRIATHLON CS INSERT NO 6 10 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X3 TRIATHLON CS INSERT NO 3 10 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X3 TRIATHLON CS INSERT NO 7 9 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X3 TRIATHLON CS INSERT NO 6 11 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
The Issue: packaging breaches of inner blister and outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 with a Certeray generator-To perform image guidance in diagnostic
The Issue: Generator may fail due to a potential short
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 3 with a Certeray generator -To perform image guidance in diagnostic
The Issue: Generator may fail due to a potential short
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 5 with a Certeray generator-To perform image guidance in diagnostic
The Issue: Generator may fail due to a potential short
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Aveir Leadless Pacemaker
The Issue: Their is a potential that electromagnetic interference may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyPoint Needle
The Issue: The needle cannula of a retractable needle may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with
The Issue: Pack and pouch label is missing the manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERENOVUS CEREBASE DA Guide Sheath
The Issue: Medos has received an increase in complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis: MedStation ES
The Issue: Automated dispensing cabinets, running affected software, and Windows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wash station: M1000 Wash Station Assembly & DITI Slide
The Issue: Products that were intended for export only which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit
The Issue: Products that were intended for export only which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange
The Issue: Products that were intended for export only which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.