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 31201–31220 of 38,428 recalls
Recalled Item: AQUAPAK 340 SW
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Code 2C4013
The Issue: for failure of the pouch packaging seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sony LMD-1951MD
The Issue: Tthe medical monitor has either not turned on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene
The Issue: False positive results for Exon 20 insertion mutations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ML 7090 Calibrated LASIK Blade (CLB)
The Issue: The ML 7090 Calibrated LASIK Blade (CLB) will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
The Issue: It was discovered that the upper left corner-shaped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.
The Issue: It was discovered that the upper left corner-shaped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5
The Issue: The labelling of units from the affected lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KYPHON EXPRESS
The Issue: The product, labeled as containing, one bevel-tipped instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Low Sorbing Infusion Set
The Issue: CareFusion is recalling the SmartSite Low Sorbing Infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS)
The Issue: In case of a system crash, images may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
The Issue: A calibration problem was detected in a specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON S2000 Automated Breast Volume Scanner (ABVS)
The Issue: There is a low probability the scanner arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET
The Issue: Defects: Cracks that may occur in the center
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Ventilator System
The Issue: Covidien is issuing a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound System
The Issue: The bolt holding the control panel of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Convenience Kit
The Issue: The labelled expiration dating of the affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Convenience Kit
The Issue: The labelled expiration dating of the affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Convenience Kit
The Issue: The labelled expiration dating of the affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC Convenience Kit
The Issue: The labelled expiration dating of the affected product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.