FDA recall Z-2943-2026

Cardinal Health 200, LLC · Class II · device

Product

Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC

Reason for recall

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

Distribution

US Nationwide. Canada.

Key facts

Status
Ongoing
Initiation date
2026-07-14
Report date
2026-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2943-2026