Recall Z-2439-2026— Medline Industries, LP

Name: FDA recall Z-2439-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-27

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-04-27. It names one FDA 510(k) clearance: K213481. Product: Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B. Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-04-27
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.