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 32861–32880 of 38,428 recalls
Recalled Item: RECLAIM DISTAL TAPERED Distal Stem
The Issue: The product can be difficult to remove from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 500 CTS
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP (Base)
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700 LAS
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 700 CTS
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP 300 CTS
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP CTS
The Issue: for sample misidentification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201
The Issue: Software Version 02-26, when used with the Central
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON S Family Ultrasound Systems at software versions VC25D
The Issue: There is a potential measurement error with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is
The Issue: Covidien is conducting a medical device field correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoWrist Stapler System User Manual Addendum and Wall Chart
The Issue: Changes were made to the Stapler EndoWrist Stapler
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code:
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture
The Issue: Sterility of device is compromised due to breach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus...
The Issue: Springs contained in the access door hinge assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing
The Issue: Swollen acid bottles due to a trace metal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
The Issue: Ability Dynamics is recalling RUSH81 Prosthetic Foot because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.