BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0 — Class II medical device recall Z-1533-2018
Terminated recall by Becton Dickinson & Company, reported 2018-05-02, distributed nationwide. Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
| Recall number | Z-1533-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2018-03-20 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2020-04-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, ES, GB, GT, GY, IE, IL, KW, LT, SE, TW |
| Reason classes | labeling, sterility |
| Model numbers | 367364 |
Product
BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364
Reason for recall
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
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-1533-2018. 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.