Data Foundry

Medical device recalls 2026

Medline medical convenience kits — Class II medical device recall Z-2994-2026

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 numberZ-2994-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-07-08
Classified2026-08-21
Reported by FDA2026-09-02
DistributedNationwide (US)
Quantity2,262 kits
Reason classessterility
UPC / GTIN / UDI-DI10193489763973, 10193489916379, 10195327182908, 10195327258917, 10195327397371, 10195327488093, 10195327679293, 10198459225758, 10198459241727, 10198459241970, 10198459313035, 10198459399916, 10888277775206, 10889942968732, 40193489763974, 40193489916370, 40195327182909, 40195327258918, 40195327397372, 40195327488094, 40195327679294, 40198459225759, 40198459241728, 40198459241971, 40198459313036 and 3 more
Lot numbers22FBC585, 22GBO880, 22HBN179, 22HBR343, 22HBT245, 22HBU967, 22KBR883, 22LBL269, 23ABM594, 23ABS340, 23ABS768, 23BBB045, 23CBS214, 23DBQ757, 23EBI617, 23EBI941, 23EBL559, 23FBC803, 23GBJ097, 23GBU042, 23HBC070, 23HBK833, 23HBP969, 23HBS862, 23HBX888, 23IBO417, 23JBU735, 23KBI060, 23LBG405, 24CBA416, 24DBD707, 24DBD912, 24EBH594, 24FBQ476, 24FBQ494, 24HBR037, 24IBF556, 24IMA157, 24IMF249, 24JBK316 and 16 more

Product

Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.

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-2994-2026. 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.