Medline medical convenience kits — Class II medical device recall Z-2997-2026
Ongoing recall by Medline Industries, LP, reported 2026-09-02, distributed nationwide. Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurospon
| Recall number | Z-2997-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-07-08 |
| Classified | 2026-08-21 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 974 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489460254, 10193489753301, 10193489864007, 10193489867381, 10195327181338, 10195327237011, 10195327283179, 10195327625689, 10198459092725, 10198459241956, 10198459558764, 40193489460255, 40193489753302, 40193489864008, 40193489867382, 40195327181339, 40195327237012, 40195327283170, 40195327625680, 40198459092726, 40198459241957, 40198459558765 |
| Lot numbers | 22CMG565, 22EDB595, 22FMF374, 22KMH219, 23AMJ184, 23BMC930, 23EMD739, 23FMD505, 23HBA720, 23HBJ773, 23HMC695, 23IBJ627, 23IBL564, 23IME138, 23JMH313, 23KMB648, 23LMB107, 23LME066, 23LMH426, 24BME326, 24EMF925, 24IMD021, 24IME838, 24JMF418, 24JMJ129, 25CMD816, 25EDA305, 25EDB254, 25JMF561 |
Product
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
Reason for recall
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
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-2997-2026. 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.