Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2439-2026·Announced 2026-06-24

Medline CVC insertion kits contain recalled Mastisol liquid adhesive

Medline central venous catheter insertion kits and Vantex PI CVC bundles are being recalled because they contain a recalled lot of Ferndale Laboratories 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 20 cm CVC Insertion Kit (ECVC6805B), the two-lumen 8.5 Fr 16 cm CVC Insertion Kit (ECVC8055A) and the Vantex PI CVC 7F 3L 20 cm bundles (ECVC6915A, ECVC6985B). 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: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT ECVC8055A VANTEX PI CVC 7F, 3L, 20CM BUNDLE ECVC6915A ECVC6985B
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

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