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 14521–14540 of 38,428 recalls
Recalled Item: Cobra x5 1-Ch EMG ET Tube
The Issue: The electrode insulating material on the Cobra EMG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobra x5 2-Ch EMG ET Tube
The Issue: The electrode insulating material on the Cobra EMG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube
The Issue: The electrode insulating material on the Cobra EMG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobra x5 2-Ch EMG ET Tube
The Issue: The electrode insulating material on the Cobra EMG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8
The Issue: May have one or more dimensional features out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame
The Issue: Modular Junction Box (MJB) cables can melt and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT7600 Integrated System
The Issue: When processing MicroSlides, slides that utilize Slot 18
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT3400 Chemistry System
The Issue: When processing MicroSlides, slides that utilize Slot 18
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic...
The Issue: Outer box labels for kit 0469247 correct, however
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NobelReplace Conical Connection (CC) PMC RP 4.3x10mm
The Issue: Dental implant cap label may incorrectly indicate implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX SARS-CoV-2 Reagents
The Issue: BD is experiencing elevated rates of potential false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restore Clinician Programmer Application Software
The Issue: The original version of the A71100 Restore Clinician
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parvovirus B19 IgG EIA kit Part No. V519IGUS
The Issue: Printed label inside the box lid of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Match Point System The Match Point System is intended to
The Issue: The procedure side indicated in the top header
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98
The Issue: A low risk of a false positive result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Anti-SARS-CoV-2 IgG Reagent Pack
The Issue: The reagent bottles may be swapped within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Anti-SARS-CoV-2 Total Reagent
The Issue: The reagent bottles may be swapped within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 The Proton Therapy System - Proteus 235 (brand
The Issue: IBA became aware of an issue to resume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No:T-SPOT.TB8
The Issue: Incorrect expiration date included in test kit labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No:T-SPOT.TB50
The Issue: Incorrect expiration date included in test kit labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.