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 10701–10720 of 38,428 recalls
Recalled Item: Celltrion DiaTrust COVID-19 Ag Rapid Test
The Issue: Point of Care (PoC) rapid test products were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast
The Issue: Incorrect bonding material used for assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast
The Issue: Incorrect bonding material used for assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model:
The Issue: Incorrect bonding material used for assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus DISPOSABLE GRASPING FORCEPS
The Issue: Forceps do not comply with Olympus standards for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triathlon Tritanium Tibial Component (Size 6)
The Issue: Stryker has discovered a potential product mix where
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with...
The Issue: The Implantable Neurostimulator Model may be susceptible to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
The Issue: The Implantable Neurostimulator (INS) cannot communicate with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare TDX SP2
The Issue: The battery wiring harness on affected wheelchairs may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroMARK Breast Biopsy Marker
The Issue: Small patient labels do not match the primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percept BrainSense Implantable Neurostimulator (INS)
The Issue: The Implantable Neurostimulator (INS) cannot communicate with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VerifyNow P2Y12 Test is designed to measure platelet P2Y12
The Issue: Two whole blood Platelet Reactivity tests exist that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System Controller
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System Controller
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System Controller
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist Device (HVAD) System
The Issue: Finnish and Turkish translation errors in HVAD controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use
The Issue: Errors and inconsistencies that were identified in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dragonfly OpStar Imaging Catheter
The Issue: There is a potential that the proximal marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.