Recall Z-2949-2026— Cardinal Health 200, LLC

Name: FDA recall Z-2949-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-14

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B. Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-07-14
Firm location: Waukegan, IL, United States

Product description

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.