Medex High Pressure Stopcock used to control the direction of IV… — Class II medical device recall Z-0512-2019
Terminated recall by Smiths Medical ASD Inc., reported 2018-12-05. Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in
| Recall number | Z-0512-2019 |
|---|---|
| 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 | 2018-11-19 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-06-05 |
| Countries outside the US | CA, MX |
| Quantity | 2,425 devices |
| Reason classes | packaging |
| Lot numbers | MX4301L, MX4331L, MX4331R |
| Model numbers | MX4301L, MX4331L, MX4331R |
Product
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
Reason for recall
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
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-0512-2019. 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.