fda_recall · device_recall · high

Medline Industries, LP — Class II recall: See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Nu…

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:35Z
Source ID
Z-2093-2026
Payload hash
e1c4bff722b622714caa7eb4

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.