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Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; ...

FDA Recall #Z-1190-2026 — Class II — December 12, 2025

Recall #Z-1190-2026 Date: December 12, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Medline Industries, LP — Northfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

40 units

Distribution

US Nationwide distribution.

Code Information

Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMD733; Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS), Lot Number 25KMC147; Medline Kit SKU CDS984857N: UDI/DI 10198459359705 (EA) 40198459359706 (CS), Lot Number 25KMJ151; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25LMB220; Medline Kit SKU DYNJ0966130K: UDI/DI 10198459442117 (EA) 40198459442118 (CS), Lot Number 25KME804; Medline Kit SKU DYNJ51440B: UDI/DI 10198459004230 (EA) 40198459004231 (CS), Lot Number 25KMI445; Medline Kit SKU DYNJ58742J: UDI/DI 10198459254710 (EA) 40198459254711 (CS), Lot Number 25KMC534; Medline Kit SKU DYNJ63781B: UDI/DI 10198459549595 (EA) 40198459549596 (CS), Lot Number 25KMB410; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25LMB068; Medline Kit SKU DYNJ82751B: UDI/DI 10198459039157 (EA) 40198459039158 (CS), Lot Number 25KMI309; Medline Kit SKU DYNJ82753C: UDI/DI 10198459446887 (EA) 40198459446888 (CS), Lot Number 25KMC126; Medline Kit SKU DYNJ907206G: UDI/DI 10198459368028 (EA) 40198459368029 (CS), Lot Number 25KBL336.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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