Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2418-2026·Announced 2026-06-24

Medline pacemaker and open heart packs contain recalled Mastisol adhesive

Medline convenience kits including pacemaker, ICD, open heart and pediatric open heart packs are being recalled over 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 Loop Pack (DYNJ61460C), Open Heart (CDS840150Y), Pacemaker (DYNJ56297C), Pacemaker PK (DYNJT3454), the Pacemaker/ICD Pack (DYNJ33822L), the PAD Open Heart pack (DYNJ900962O) and Pediatric Open Heart (DYNJ54238L), 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: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C…
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

See all →

Moderate
Medline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
High
Medline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
Severe
Medline surgical kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
Moderate
Medline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Moderate
Medline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21

Same hazard · component defect