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 37561–37580 of 38,428 recalls
Recalled Item: OrthoPediatrics PediLoc Locking Plate System
The Issue: The device is a Left 8 hole plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Xcelera Connect
The Issue: Xcelera Connect R2.1 L 1 SP2 , incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE has become aware of multiple issues affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE has become aware of multiple issues affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product...
The Issue: Sterility of product may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage:
The Issue: Sterility of product may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fuze Manual Tilt Wheelchair. Fuze T50
The Issue: The hex bolt head might shear and cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
The Issue: It has come to firm's attention that, in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health
The Issue: Carestream DRX-1 System batteries manufactured before June 2012
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware through complaints of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Concha Therm Neptune Humidifier
The Issue: Speaker Failure. If the speaker fails and an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Medical Xprezzon Bedside Monitor
The Issue: There were reports that a certain combination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.
The Issue: Anspach was contacted by a hospital to inform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting
The Issue: Anspach was contacted by a hospital to inform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Distraction Screws of 3 different sizes: 12mm
The Issue: This letter is to notify you that several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedural Trays: Merit's Custom Total Hip Pack
The Issue: Custom Procedural trays contain Stryker Hytrel Togas which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune Rover Waste Management System
The Issue: Stryker has received two reports of serious injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.