Cellfina Prep Pack — Class II medical device recall Z-0749-2017
Terminated recall by Ulthera Inc, reported 2016-12-21. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Us
| Recall number | Z-0749-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ulthera Inc, Mesa, AZ, United States |
| Recall initiated | 2016-11-14 |
| Classified | 2016-12-13 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2017-09-13 |
| Countries outside the US | AT, CH, DE, ES, FR, GB, IT, NL |
| Quantity | 6,562 units |
| Reason classes | sterility |
| Model numbers | CP1 |
Product
Cellfina Prep Pack, Part No. CP1
Reason for recall
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
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-0749-2017. 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.