Class II — Intersurgical Inc
| Recalling firm | INTERSURGICAL, INC. |
|---|---|
| Registered facility | INTERSURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 | Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000 |
| Quantity | 1340 |
| Distribution | Distributors in IL, NJ, NV, TX, UT. |
| Initiated | 2018-04-25 |
| Classified | 2018-06-27 |
| Terminated | 2019-04-09 |
| Recall number | Z-2302-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intersurgical Inc (Z-2302-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80250/
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