medfusion Stopcock — Class II medical device recall Z-0155-2022
Terminated recall by Smiths Medical ASD Inc., reported 2021-10-27. Product has a lack of sterility assurance
| Recall number | Z-0155-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2018-05-10 |
| Classified | 2021-10-20 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-09-15 |
| Countries outside the US | AT, CH, DE, ES, GB, HU, IT, NZ, PL, SE, SI |
| Quantity | 933,518 units |
| Reason classes | sterility |
| Serial numbers | 081-101GE, 081-101GEE, 081-101NE, 081-101RE, 081-102BE, 081-102GE, 081-102GEE, 081-102NE, 081-102RE, 089-101E, 1470293701, 1470312301, 1570316801, 1570316901, 1570319201, 1570323801, 1570340901, 1570341001, 1570342601, 1570342701, 1570342901, 1570343001, 1570343101, 1570343201, 1570343301 and 28 more |
| Model numbers | 081-101BE, 081-101GE, 081-101GEE, 081-101NE, 081-101RE, 081-102BE, 081-102GE, 081-102GEE, 081-102NE, 081-102RE, 089-101E, 888-101BE, 888-101GE, 888-101GEE, 888-101NE, 888-101RE |
Product
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE
Reason for recall
Product has a lack of sterility assurance
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-0155-2022. 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.