Official recall notice

FDA DeviceClass IINotable

Cardinal Health Presource Kits Recall (Aug 2026)

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

Recall date
2026-08-19
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

1) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1

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