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 15501–15520 of 38,428 recalls
Recalled Item: Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T...
The Issue: A "Remove USB Device 2" false alarm may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description:...
The Issue: A "Remove USB Device 2" false alarm may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no.
The Issue: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PreludeSYNC DISTAL Radial Compression Devices
The Issue: During the sterilization of radial compression devices, some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VITEK 2 Gram-positive Susceptibility Card is intended for use
The Issue: There is a potential for the occurrence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endocuff Vision: models ARV 110
The Issue: Updated Instructions For Use- to contraindications and potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS 5 ml
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS 2-fach Druckmesset mit Option
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS 5 ml
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS 5 ml
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS 5 ml
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: medex LogiCal 5mL Closed Blood Sampling System
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS-5ML
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS-5ML
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS-5ML Zweifach set
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS-5ML
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex CBSS-5ML Antishunt set
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical medex HemoDraw Plus Closed Blood Sampling Set with
The Issue: Reported pressure shifts and incorrect pressure readings in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product
The Issue: Intermittent failure of a signal being sent to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies
The Issue: Investigation into a biocompatibility test discrepancy where a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.