Pro Series Fertility Device — Class II medical device recall Z-1363-2021
Ongoing recall by Tenderneeds Fertility LLC, reported 2021-04-14. Device was distributed without a proper marketing authorization.
| Recall number | Z-1363-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tenderneeds Fertility LLC, Greenville, IN, United States |
| Recall initiated | 2020-12-23 |
| Classified | 2021-04-06 |
| Reported by FDA | 2021-04-14 |
| UPC / GTIN / UDI-DI | 00644042788139 |
Product
Pro Series Fertility Device (SKU 644042788139)
Reason for recall
Device was distributed without a proper marketing authorization.
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-1363-2021. 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.