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 14781–14800 of 38,428 recalls
Recalled Item: PowerLoc MAX Power Injectable Infusion Port Access Kit
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerLoc MAX Power Injectable Infusion Set
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set Port Access Kit
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set with Y Injection Site and Medegen
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set AllPoints Port Access System
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set myPICK Port Access Kit
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial...
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStep Huber Needle Set
The Issue: development of cracks or breaks in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phillips Module Charger
The Issue: A problem has been detected with the Philips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phillips 3.7V Rechargeable Li-Polymer Battery
The Issue: A problem has been detected with the Philips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chembio DPP¿ Micro Reader for use with the DPP¿ COVID-19
The Issue: FDA revocation of the Emergency Use Authorization due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phillips Charging Station
The Issue: A problem has been detected with the Philips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the
The Issue: FDA revocation of the Emergency Use Authorization due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chembio DPP¿ Micro Reader II for use with the DPP¿
The Issue: FDA revocation of the Emergency Use Authorization due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anjon Bremer Molded Crown. bone fixation fastener for spinal use.
The Issue: High rate of galling of one threaded component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mueller Sports Medicine Hybrid Wraparound Knee Support
The Issue: Natural rubber is present in Hybrid Wraparound Knee
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal
The Issue: Removal for a specific lot, lot number 70128207,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.