CLASS II Device recall · Reported 11 Jul 2018 · FDA Enforcement Report

Angio-Seal Evolution Vascular Closure Device recalled by Terumo Medical

Terumo Medical is recalling Angio-Seal Evolution Vascular Closure Device, distributed in 12 states. The recall was initiated on 9 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes5980075, 5980077

Quantity recalled240

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-2337-2018
FDA event ID: 80242
Recalling firm: Terumo Medical, Somerset, NJ
Classification: Class II
Status: Terminated
Recall initiated: 9 Apr 2018
FDA classified: 29 Jun 2018
Reported: 11 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

9 Apr 2018	Recall initiated by company
29 Jun 2018	Classified by FDA	+81 days
11 Jul 2018	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

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Where it was distributed

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

Alabama California Florida Iowa Indiana Michigan Missouri North Carolina New York South Dakota Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

5980075, 5980077

Where was it sold?

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

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

More recalls from Terumo Medical

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31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Sur-vet Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states
31 Jul 2019Device	CLASS II	Terumo Needle, Product recalled by Terumo Medical	Terumo Medical	Sterility	12 states

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide