smiths medical portex Loss of Resistance Device — Class II medical device recall Z-0152-2022
Terminated recall by Smiths Medical ASD Inc., reported 2021-10-27. The labeling was missing information on sterilization and prohibition of reuse.
| Recall number | Z-0152-2022 |
|---|---|
| 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 | 2020-12-08 |
| Classified | 2021-10-19 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-08-04 |
| Countries outside the US | AE, AU, BE, CA, CH, CZ, DE, ES, FR, GB, IE, IL, IT, NL, NZ, SE, SI, ZA |
| Quantity | 3,420 devices |
| Reason classes | labeling |
| Lot numbers | 3980977, 3986734, 3994302, 3994303, 4001003 |
| Model numbers | 100/398/000 |
Product
smiths medical portex Loss of Resistance Device, REF 100/398/000
Reason for recall
The labeling was missing information on sterilization and prohibition of reuse.
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-0152-2022. 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.