The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2440-2026·Announced 2026-06-24

Medline driveline and port dressing kits contain recalled Mastisol adhesive

The Medline Driveline Management Kit and Port Dressing Change Kit are being recalled because they contain a recalled lot of 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 Driveline Management Kit (EBSI1688) and the Port Dressing Change Kit (EBSI1328A). 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.

Affected product is UDI-DI 10653160370130, lot 2025102890, and UDI-DI 10653160382980, lot 2025103090. 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 above and follow the instructions issued by Medline.

The recalled product

Product
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A
Manufacturer
Medline Industries, LP
Category
Medical Device — Dressing kit
Hazard
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 →

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