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 6601–6620 of 38,428 recalls
Recalled Item: MYNXGRIP 5F
The Issue: Cordis became aware that the label for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Their is the potential that the percutaneous pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VADER pedicle system
The Issue: icotec has received notification of one revision that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYNXGRIP 6F/7F
The Issue: Cordis became aware that the label for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDS 3 CSF External Drainage System
The Issue: Sterility assurance cannot be guaranteed for external drainage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: External Drainage System Collection Bag
The Issue: Sterility assurance cannot be guaranteed for external drainage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Captus 4000e Thyroid Uptake Systems- Intended to be used by
The Issue: Spring arm failure with Captus 4000e Thyroid Uptake
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack
The Issue: Affected lots may experience increased calibration failures or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed
The Issue: A manufacturing event may contribute to elevated rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed...
The Issue: A manufacturing event may contribute to elevated rates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B
The Issue: The following was missing from the Contraindications Statement:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY
The Issue: Due to potential breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The device is a mobile x-ray system designed to work
The Issue: When the key switch is turned on, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Actim PROM dipstik
The Issue: Interference testing has shown that the presence of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal CARDIAC CATH SET-UP KIT PGYBK
The Issue: Kit were manufactured and distributed with Edwards Life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Ultrasensitive Insulin only used on the DxI 9000 Access
The Issue: There is an issue with the Access Ultrasensitive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior
The Issue: There are potential performance issues found in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QMS Tacrolimus Calibrators
The Issue: Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AcuMatch Hip System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe Shoulder System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.