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

