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 24901–24920 of 38,428 recalls
Recalled Item: Cordis S.M.A.R.T. Flex Vascular Stent System
The Issue: Deployment Difficulty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part
The Issue: A complaint was received on January 1, 2017
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MotoCLIP(TM) Super Elastic Fusion System
The Issue: Seven 18mm x 18mm x 18 mm implants
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule
The Issue: When a user switches on MR1100 Receiver, even
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit. Dialyzer
The Issue: Firm has received reports of device operators failing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster MobiCath Bi-Directional Guiding Sheath
The Issue: One side of the MobiCath Bi-Directional Guiding Sheath
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and
The Issue: After a submission for CLIA database update from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legionella IFA (IF0950) intended for qualitatively detecting and...
The Issue: After a submission for CLIA database update from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA...
The Issue: Euro Diagnostica has identified a deviation in one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates.
The Issue: Digital templates were created with the incorrect files
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR" Avant-garde
The Issue: Software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
The Issue: Software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mevatron M2/Primus Mid-Energy PRIMUS HI
The Issue: Software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE" MV System
The Issue: Software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modera Modular Pedicle Screw System Shank Insertion Instrument
The Issue: This is a retrospective recall of an instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Chemistry Analyzer AU680/AU5800
The Issue: Beckman Coulter is recalling the Rack ID Labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELL-DYN Ruby System: List Number: 08H6701
The Issue: The Pump Relay Printed Circuit Board Assembly (PCBA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II
The Issue: A damaged temperature sensor at the endoscope's tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UOC Femoral Driver
The Issue: The locking lever pin component of the femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.