Class II — Intersurgical Inc
| Recalling firm | INTERSURGICAL, INC. |
|---|---|
| Registered facility | INTERSURGICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device was assembled with the incorrect exhalation port which can cause gas leakage. |
| Product | Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. |
| Quantity | 200 devices |
| Distribution | All of the devices were shipped to the same distributor (McKesson). |
| Initiated | 2020-11-11 |
| Classified | 2020-12-30 |
| Terminated | 2022-08-09 |
| Recall number | Z-0753-2021 |
| 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-0753-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86800/
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