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 5161–5180 of 38,428 recalls
Recalled Item: Trevo ProVue
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo Trak 21 Microcatheter
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synchro .014"guide wire
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DAC 044 115cm
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo NXT ProVue 3 x 32
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo XP ProVue Retriever 4 x 20
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlowGate2 8F x 85cm
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo Pro 14 Microcatheter
The Issue: Neurovascular devices did not meet the minimum sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade IOMAX Cortical Module
The Issue: There is the potential that an electroneurodiagnostic medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURGIFOAM" Absorbable Gelatin Powder Kit
The Issue: Some applicator tips from these lots had open
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests)
The Issue: The potential for falsely elevated patient sample results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests)
The Issue: The potential for falsely elevated patient sample results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: muRata Vios Monitoring System Model 2050
The Issue: During the set-up and workflow to begin Vios
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology
The Issue: Capacitors in certain Prucka 3 Amplifiers used with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preview Strep A
The Issue: Wondfo USA has identified unauthorized distribution of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clarity and Clarity Diagnostics LLC
The Issue: Wondfo USA has identified unauthorized distribution of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streptococcal A rapid test kits
The Issue: Wondfo USA has identified unauthorized distribution of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streptococcal A rapid test kits
The Issue: Wondfo USA has identified unauthorized distribution of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Independent Medical Co-op Inc.
The Issue: Wondfo USA has identified unauthorized distribution of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE
The Issue: It has been identified that testing documentation does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.