Recall Z-2032-2026— Medline Industries, LP

Name: FDA recall Z-2032-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-03-19. It names one FDA 510(k) clearance: K140369. Product: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133. 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-03-19
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K140369 — MEDLINE NEURO SPONGEMedline Industries, Inc.·cleared 2014-09-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133

Reason for recall

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.

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