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 20121–20140 of 38,428 recalls
Recalled Item: ARROW¿ Bipolar Electrode Catheter with shrouded pins
The Issue: Products are labeled with an incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide
The Issue: The assembly of the needle guides were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide
The Issue: The assembly of the needle guides were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Pheno Interventional Fluoroscopic X-Ray System
The Issue: Temperature of the detector may fall out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q Interventional Fluoroscopic X-Ray System
The Issue: Temperature of the detector may fall out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers...
The Issue: Affected lots of reprocessed arthroscopic shavers may display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex XN-Series Fluorocell PLT
The Issue: The fluorescent platelet counts (PLT-F) and immature platelet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microdot Xtra blood glucose test strips
The Issue: The firm reported that a faulty cutting/punching machine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #:
The Issue: When creating a correction plan with the Correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO V-PRO 1
The Issue: There is the potential for a scenario where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Li-ion battery packs used in BIS Vista and BIS View
The Issue: Revised replacement instructions for the Li-ion battery packs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak
The Issue: There was a potential that a 25-gauge infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYTEC Stop Solution (Allergy)
The Issue: Some of the Stop Solution bottles, a caustic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Binding Site Human IgM Kit (for SPAPLUS)
The Issue: After running the calibration curve, the recovery of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PR1000 Pivot Rehab Bed AC powered adjustable bed.
The Issue: Under certain conditions, when pivoting bed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YUKON Polyaxial Screws (3.5 X 12 mm
The Issue: Screws had a manufacturing error that could prevent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM CKMB Calibrator
The Issue: A potential bias was identified with certain kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur CKMB Calibrator
The Issue: A potential bias was identified with certain kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM CKMB Master Curve Material
The Issue: A potential bias was identified with certain kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.