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Open, Classified

Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A

FDA Recall Z-2440-2026 · Posted 2026-06-12

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-04-27
Product Quantity49,654 kits total

Reason for Recall

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

Firm Action

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution. OUS distribution pending.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213481Medline General Surgery TrayMedline Industries, Inc. · 2022-05-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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