FDA Medical Device · Z-2943-2026

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

Class II · Ongoing

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

Affected lots / codes — check yours against this1) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:12206¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 2) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ; 3) SOP30SPBCC, UDI-DI: 10195594687137(each), 50195594687135(case), Lot Number:13289¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ;

Recalling firm: Cardinal Health 200, LLC, Waukegan, IL
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 456 kits
Distribution: US Nationwide. Canada.
Recall initiated: July 14, 2026
Classified: August 13, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2943-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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