FDA Device Intelligence
HomeKIMBERLY-CLARK GLOBAL SALES, INC. › U by Kotex

U by Kotex

KIMBERLY-CLARK GLOBAL SALES, INC. · Model Tampon · UDI-DI 00036000475449

HEB
10
510(k) clearances
11,865
Adverse events (13 deaths)
36
Recalls
95
Facilities

Description

U BY KOTEX SUPER PREMIUM CLICK TAMPONS MULTIPAK JUMBO 50 CT

Recalls

DateFirmReason
2025-12-26GOLD STAR DISTRIBUTION INCPotential exposure of rodents and rodent activity in the distribution center.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.
2025-02-17DAYE (ANNE'S DAY LTD)Product lacks 510(k) clearance.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.