fda_recall · device_recall · high

Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B…

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:37Z
Source ID
Z-2117-2026
Payload hash
f1bba0950372da2d42f83f1f

Summary

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL)… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.