Data Foundry

Medical device recalls 2019

U by Kotex¿ Sleek¿ — Class II medical device recall Z-0751-2019

Terminated recall by Kimberly-Clark Corporation, reported 2019-01-23, distributed nationwide. Potential for tampon to come apart upon removal.

Recall numberZ-0751-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmKimberly-Clark Corporation, Neenah, WI, United States
Recall initiated2018-12-11
Classified2019-01-17
Reported by FDA2019-01-23
Terminated2021-06-02
DistributedNationwide (US)
Countries outside the USCA
Quantity68,852,076 units
Lot numbersXM700604X, XM700904X, XM702304X, XM702404X, XM702504X

Product

U by Kotex¿ Sleek¿, Regular Tampons, 3 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-0751-2019. 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.