Smoothbore breathing system with exhalation port 22 mm Device REF #:… — Class II medical device recall Z-0753-2021
Terminated recall by Intersurgical Inc, reported 2021-01-06. The device was assembled with the incorrect exhalation port which can cause gas leakage.
| Recall number | Z-0753-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersurgical Inc, East Syracuse, NY, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-12-30 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2022-08-09 |
| Quantity | 200 devices |
| Reason classes | packaging |
| Lot numbers | 4200283, 4200286 |
| Model numbers | B0062001 |
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.
Reason for recall
The device was assembled with the incorrect exhalation port which can cause gas leakage.
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-0753-2021. 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.