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-2020-2026
Brand: Medline Industries
Classification: Class II
Units affected: 1294 kits
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.

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 CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22EBQ566; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22OBM500; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22BBH011; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22ABF773; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21KBM498; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21JBJ185; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21IBM809; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21IBE910; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21HBF657; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21FBQ527; Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 21EBC912; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349, Lot Number: 26BBJ475; Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348, UDI/DI case 40198459589349, Lot Number: 25LBD824; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21IME243; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21GMD919; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21EMB698; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21CMB708; Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163, UDI/DI case 40193489715164, Lot Number: 21BMB155; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 22FDA247; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 22BDB470; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21KDB891; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21IDA884; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21DDB913; Medline Kit Number/SKU DYNJ51677B: UDI/DI each 10193489219098, UDI/DI case 40193489219099, Lot Number: 21DDB294; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21FBB400; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21EBN493; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21DBP964; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21OBA488; Medline Kit Number/SKU DYNJ55955C: UDI/DI each 10193489426021, UDI/DI case 40193489426022, Lot Number: 21ABF008; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23KBP837; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23GBS485; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23FBJ867; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23EBD035; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 23BBB609; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 22FBW392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 22OBB247; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25KBH559; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25HBT244; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25HBQ392; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 25DBF266; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24LBN800; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24KBJ090; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24GBY270; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24EBA930; Medline Kit Number/SKU DYNJ67789A: UDI/DI each 10193489945645, UDI/DI case 40193489945646, Lot Number: 24BBU360.
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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