CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

Medline convenience kits: Cvc Insertion Kit ECVC6805B Cvc recalled

Medline Industries is recalling Medline convenience kits: Cvc Insertion Kit ECVC6805B Cvc Insertion Kit ECVC8055A Vantex, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190

Quantity recalled49,654 kits total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2439-2026
FDA event ID: 98951
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 27 Apr 2026
FDA classified: 12 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Apr 2026	Recall initiated by company
12 Jun 2026	Classified by FDA	+46 days
24 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution. OUS distribution pending.

Nationwide

Questions about this recall

Is Medline convenience kits: Cvc Insertion Kit ECVC6805B Cvc Insertion Kit ECVC8055A Vantex recalled?

Yes. Medline Industries recalled Medline convenience kits: Cvc Insertion Kit ECVC6805B Cvc Insertion Kit ECVC8055A Vantex on 27 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2439-2026.

Why was it recalled?

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

Which lots are affected?

ECVC6805B UDI-DI 10653160387428 Lot 2025120890 ECVC8055A UDI-DI 10653160387848 Lot 2025112690 ECVC6915A UDI-DI 10653160389439 Lot 2025102790 ECVC6985B UDI-DI 10653160388272 Lot 2025103190

Where was it sold?

US Nationwide distribution. OUS distribution pending.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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