Medline medical procedure kits — Class II medical device recall Z-2027-2026
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-2027-2026 |
|---|---|
| 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 | 263,739 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489219999, 10193489223903, 10193489224344, 10193489233391, 10193489246308, 10193489248265, 10193489316353, 10193489317763, 10193489320718, 10193489324778, 10193489330281, 10193489333992, 10193489336917, 10193489338058, 10193489338386, 10193489339468, 10193489345230, 10193489345377, 10193489351378, 10193489356809, 10193489394603, 10193489421491, 10193489422801, 10193489434811, 10193489444353 and 475 more |
| Lot numbers | 20LDB704, 20LMF383, 20LMF885, 20XBH472, 20XBI763, 21ABB244, 21ABB310, 21ABE041, 21ABF170, 21ABG163, 21ABI850, 21ABJ333, 21ABL202, 21ABL428, 21ABM906, 21ABN134, 21ABN541, 21ABO348, 21ABP128, 21ABQ539, 21ABQ601, 21ABQ834, 21ABT062, 21ABW391, 21ABW416, 21ABX087, 21ADB392, 21AKA907, 21AKB176, 21AMA054, 21AMA058, 21AME192, 21AME606, 21BBC401, 21BBD873, 21BBE062, 21BBF461, 21BBG003, 21BBH071, 21BBH899 and 460 more |
Product
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
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-2027-2026. 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.