FDAClass II · Medical device · Recalled May 6, 2026

Medline 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-2018-2026
Brand: Medline Industries
Classification: Class II
Units affected: 208 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

Affected products

Medline 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: Medline Kit Number/SKU DYNJ32854B: UDI/DI each 10198459413414, UDI/DI case 40198459413415, Lot Number : 25GBU656; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25GMD214; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25FMC376; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25DMJ030; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25BME902; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25AMJ032; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24IMH612; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24EME486; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24DMD315; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 26BMD607; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 25JMD196.
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.

Report a data error on this page