CLASS II Device recall · Reported 4 Jul 2018 · FDA Enforcement Report

Flexible Smoothbore Breathing Circuit with Exhalation Port recalled

Intersurgical is recalling Flexible Smoothbore Breathing Circuit with Exhalation Port, Product No. 80062000, distributed in Illinois, New Jersey, Nevada, Texas, Utah. The recall was initiated on 25 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.

Quantity recalled1340

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-2302-2018
FDA event ID: 80250
Recalling firm: Intersurgical, E. Syracuse, NY
Classification: Class II
Status: Terminated
Recall initiated: 25 Apr 2018
FDA classified: 27 Jun 2018
Reported: 4 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Apr 2018	Recall initiated by company
27 Jun 2018	Classified by FDA	+63 days
4 Jul 2018	Published in enforcement report	+7 days

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

Reason for recall

When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover or block the exhalation port. This could potentially pose a serious health risk to the patient.

Product as listed by the FDA

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

Where it was distributed

Distributors in IL, NJ, NV, TX, UT.

Illinois New Jersey Nevada Texas Utah

Questions about this recall

Why was it recalled?

Which lots are affected?

0261604, 0671602, 0671603, 0741609, 0751601 , 0821605, 0821606, 0891605, 0891606, 0951609, 0961601, 1751601 , 0011802, 0011803, 0021803, 0081808 and 0161805.

Where was it sold?

Distributors in IL, NJ, NV, TX, UT.

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.

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