fda_recall · device_recall · high

Medline Industries, LP — Class II recall: See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS…

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:41Z
Source ID
Z-2097-2026
Payload hash
4dfb2496c54ecb058e64f371

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.