Medline medical procedure kits — Class II medical device recall Z-2019-2026

Ongoing recall by Medline Industries, LP, reported 2026-05-06. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medlin

Recall number	`Z-2019-2026`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medline Industries, LP, Northfield, IL, United States
Recall initiated	2026-03-19
Classified	2026-04-30
Reported by FDA	2026-05-06
Quantity	2,228 kits
Reason classes	sterility
UPC / GTIN / UDI-DI	`10195327191689`, `10195327267407`, `10195327643713`, `10195327671136`, `10198459059216`, `10198459334146`, `10198459568817`, `10198459674907`, `40195327191680`, `40195327267408`, `40195327643714`, `40195327671137`, `40198459059217`, `40198459334147`, `40198459568818`, `40198459674908`
Lot numbers	`22IBB948`, `22KBV773`, `22KME285`, `22KMH108`, `22LBG835`, `23BBA368`, `23BMB495`, `23BMH200`, `23CBD133`, `23CMH103`, `23DBC424`, `23EBR729`, `23JBW720`, `23JMB165`, `23KMJ648`, `23LBH114`, `24ABS878`, `24BBP259`, `24CMG724`, `24EBH347`, `24EME289`, `24FBL453`, `24GBC544`, `24HBN580`, `24IBQ393`, `24IMC899`, `24IMD398`, `24JMH963`, `24KBU249`, `24LMA598`, `25CBF213`, `25CMH298`, `25DBC120`, `25DMF918`, `25EMB523`, `25FBB129`, `25FBE608`, `25FBQ773`, `25FMG199`, `25GBJ601` and 12 more

Product

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2019-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.