Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2421-2026·Announced 2026-06-24

Medline ENT and ear procedure kits contain recalled Mastisol adhesive

Medline convenience kits for discectomy, ear, ENT and head and neck procedures are being recalled because they contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: FDA Class II recall where the described consequence is that a component becomes unusable rather than any patient hazard, which fits the Moderate band.

Plain-English summary

Medline convenience kits are being recalled, covering the Discectomy Pack (DYNJ86476B), Ear kits (DYNJ81460C, DYNJ900004J, DYNJ901779J, DYNJ902900F), the Ear Pack (DYNJ81419D), the ENT Pack (DYNJ40498B) and the Head & Neck CDS kit (DYNJ901246J), among the SKUs listed in the recall notice. The action covers 49,654 kits in total across the connected Medline Mastisol recalls.

The stated reason is that the kits contain a recalled lot of Ferndale Laboratories Mastisol Liquid Adhesive. According to the notice, the butyrate tubing may crack during actuation and render the product unusable for application. The FDA classified the action as Class II. The source does not describe any patient hazard beyond the product being unusable.

Distribution was nationwide in the United States, with distribution outside the United States pending.

Facilities should identify affected stock using the kit numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by Medline.

The recalled product

Product: Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EAR PACK DYNJ81419D ENT PACK DYNJ40498B HEAD & NECK CDS DYNJ901246J JEWISH DR SEVERTSON EAR DYNJ909252C JEWISH HEAD&NECK DYNJ909255C KIT HEAD…
Manufacturer: Medline Industries, LP
Category: Medical Device — Surgical convenience kit
Hazard: component-defect
cracking-tubing
supplier-recall
class-ii
Affected units: 49,654

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 34 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 34 products in this recall →

Same manufacturer · Medline Industries, LP

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