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 9141–9160 of 38,428 recalls
Recalled Item: Philips MR 7700 System
The Issue: Gradient Coil may act as a heat source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenia Elition S MR System
The Issue: Gradient Coil may act as a heat source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenia Elition X MR System
The Issue: Gradient Coil may act as a heat source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Upgrade to MR 7700 System
The Issue: Gradient Coil may act as a heat source
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate
The Issue: Fetal Spiral Electrode (FSE) spiral tip of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201)
The Issue: An app, part of a continuous glucose monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BBL Chocolate II Agar- IVD for the isolation and cultivation
The Issue: Boxes contain a reduced concentration of Nicotinamide Adenine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica MICROSYSTEMS M530 OHX
The Issue: There is a potential issue resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica MICROSYSTEMS Provido
The Issue: There is a potential issue resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica MICROSYSTEMS Proveo 8
The Issue: There is a potential issue resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The 4Kscore Test is an in vitro serum or plasma
The Issue: SPM software anomalies that may lead to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Packs IV START TRAY I-Intended for IV
The Issue: Presource Kits contains the ICU MicroClave Clear Connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Packs IV START KIT-Intended for IV Access
The Issue: Presource Kits contains the ICU MicroClave Clear Connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Presource Packs IV START KIT- Intended for IV
The Issue: Presource Kits contains the ICU MicroClave Clear Connector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III
The Issue: Internal comparison studies revealed unacceptable, light staining. Light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline CISION Sterile Blades. Labeled as follows with corresponding Item
The Issue: of the blade puncturing the outer foil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BECKMAN COULTER IRISpec CA/CB/CC control
The Issue: Beckman Coulter has become aware of an increase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeVilbiss
The Issue: The firm has received complaints of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Natus Cranial Access Kit is designed to be a complete
The Issue: Due to Cranial Access Kits containing recalled sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foot Controlled Electrosurgical Suction Coagulator
The Issue: Suction ports may potentially be occluded on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.