Device product

Medline EBSI Kit EBSI1534

Z-2414-2026

April 27, 2026

Class II

Product summary

Firm: Medline Industries, LP
Event: Event 98951
Status: Ongoing
Classification: Class II
Quantity: 49,654 kits total
Official record key: device-enforcement:Z-2414-2026

Official wording

Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Code information: UDI-DI 10653160350507 Lot 2025110490

Distribution pattern: US Nationwide distribution. OUS distribution pending.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.