U by Kotex¿ Sleek¿ — Class II medical device recall Z-0749-2019
Terminated recall by Kimberly-Clark Corporation, reported 2019-01-23, distributed nationwide. Potential for tampon to come apart upon removal.
| Recall number | Z-0749-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kimberly-Clark Corporation, Neenah, WI, United States |
| Recall initiated | 2018-12-11 |
| Classified | 2019-01-17 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2021-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 68,852,076 units |
| UPC / GTIN / UDI-DI | 10036000426646 |
| Lot numbers | NN628101A, NN628101B, NN628201A, NN628201B, NN629401A, NN629401B, NN631201B, NN631301A, NN632113B, NN632213A, NN633813D, NN634113B, NN634213A, NN635113C, NN703113A, NN703113B, NN705613C, NN706313C, NN706313D, NN706413C, NN706413D, NN707713C, NN707713D, NN711313C, NN711313D, NN711413A, NN713013B, NN713113A, NN714313B, NN714413A, NN714413B, NN719313B, NN719413A, NN722013B, NN722113A, NN722113B, NN722213A, NN724713A, NN724713B, NN726713D and 34 more |
Product
U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
Reason for recall
Potential for tampon to come apart upon removal.
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-0749-2019. 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.