FDAClass II · Medical device · Recalled May 6, 2026

Centurion medical procedure kits recall — Medline Industries, LP

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2028-2026
Brand: Medline Industries
Classification: Class II
Units affected: 3000 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715

Affected products

Centurion medical procedure kits

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: UDI/DI EACH 10653160323068, UDI/DI case 40653160323069. Lot Numbers: 23JBY390, 23IBS518, 23FBW067, 23CBO045, 22HBC645, 22GBL079, 22DBP674, 22ABU694, 21IBM298, 21IBM495, 21GBB532, 21EBR576, 21CBL756, 21ABI942, 26ABG606, 25LBS129, 25IBK286, 25GBB222, 25DBH934, 25BBD132, 24LBO080, 24JBW176, 24HBT740, 24EBU727, 24ABW463.
Distribution: Worldwide distribution.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98664
Recall initiated: March 19, 2026
FDA classified: April 30, 2026
FDA report date: May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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