Data Foundry

Medical device recalls 2018

Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm — Class II medical device recall Z-2302-2018

Terminated recall by Intersurgical Inc, reported 2018-07-04, distributed in IL, NJ, NV, TX, UT. When assembling an HME or Filter on this breathing circuit the tubing may be pushed up and inadvertently cover

Recall numberZ-2302-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIntersurgical Inc, E. Syracuse, NY, United States
Recall initiated2018-04-25
Classified2018-06-27
Reported by FDA2018-07-04
Terminated2019-04-09
DistributedIL, NJ, NV, TX, UT
Quantity1,340

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2302-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.