fda_recall · device_recall · high

Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A

Event date
2026-05-13 00:00:00Z
Observed
2026-07-09 22:52:41Z
Source ID
Z-2122-2026
Payload hash
e14c636a8a605e15e82b3a20

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.