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 21401–21420 of 38,428 recalls
Recalled Item: Retractor f/Sciatic Nerve
The Issue: There is a potential for microspores to form
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Retractor f/Sciatic Nerve Long
The Issue: There is a potential for microspores to form
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Head Component
The Issue: Two lots of different sized modular heads potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Head Component
The Issue: Two lots of different sized modular heads potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Think Surgical Cutter
The Issue: There is a potential for the cutter head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR Surgical Suite Option Product The MR Surgical Option when
The Issue: There is a potential safety issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
The Issue: for LFA strips to improperly wick which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C2 CryoBalloon Focal Catheter
The Issue: The catheter alignment arrow printed onto the strain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741
The Issue: The patient support head holder could contact the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741
The Issue: The patient support head holder could contact the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351
The Issue: The patient support head holder could contact the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert
The Issue: The affected products were inadvertently packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert
The Issue: The affected products were inadvertently packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert
The Issue: The affected products were inadvertently packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in...
The Issue: leak at distal open end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert
The Issue: The affected products were inadvertently packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Hi-Low Exam Tables
The Issue: One lot, the wire harness was over-crimped on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
The Issue: The Discovery IGS and Innova IGS systems may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
The Issue: The Discovery IGS and Innova IGS systems may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter
The Issue: Thrombogenicity test results demonstrated that both the test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.