Skip to content
Recall Observatory FDA recall evidence

Device product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U

Z-2014-2026

March 19, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98664
Status
Ongoing
Classification
Class II
Quantity
160 kits
Official record key
device-enforcement:Z-2014-2026

Official wording

Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Code information: UDI/DI each 10193489634594, UDI/DI case 40193489634595, Lot Number: 24ILA931

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification