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Recall Observatory FDA recall evidence

Device product

Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L

Z-2420-2026

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-2420-2026

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 10198459293535 Lots 26AME511 26AMG737

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.