Data Foundry

Medical device recalls 2026

Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR… — Class II medical device recall Z-1190-2026

Ongoing recall by Medline Industries, LP, reported 2026-02-04, distributed nationwide. Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to c

Recall numberZ-1190-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2025-12-12
Classified2026-01-28
Reported by FDA2026-02-04
DistributedNationwide (US)
Quantity40 units
Reason classespackaging
UPC / GTIN / UDI-DI10198459004230, 10198459039157, 10198459254710, 10198459311451, 10198459359705, 10198459368028, 10198459442117, 10198459446887, 10198459549595, 40198459004231, 40198459039158, 40198459254711, 40198459311452, 40198459359706, 40198459368029, 40198459442118, 40198459446888, 40198459549596
Lot numbers25KBL336, 25KMB410, 25KMC126, 25KMC147, 25KMC534, 25KMD733, 25KME804, 25KMI309, 25KMI445, 25KMJ151, 25LMB068, 25LMB220

Product

Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.

Reason for recall

Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.

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-1190-2026. 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.