The Recall Desk
ModerateFDA (Devices)·Z-1190-2026·Announced 2026-02-04

Head and neck procedure packs recalled over cracking adhesive tubing

Medline is recalling 40 units of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites a supplier component recall over cracking tubing with no stated consequence or reported harm.

Plain-English summary

Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering the Middle Ear CDS under Medline kit SKU CDS984347O, the Head and Neck CDS-LF under SKU CDS984857N, the Neck Pack-LF under SKU DYNJ0966130K, the Neckline Pack-LF under SKU DYNJ51440B and the Thyroid Pack, among the kits listed in the enforcement record.

The record states the 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.

The record lists 40 units, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.

The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.

The recalled product

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, K
Manufacturer
Medline Industries, LP
Category
Medical Device — Procedure kit
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Medline Kit SKU CDS984347O: UDI/DI 10198459311451 (EA) 40198459311452 (CS)
  • Lot Number 25KMD733
  • 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
  • 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
  • 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)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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