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HERE WE FLO LTD · Model MEGA-AMZ-TAMP-1 · UDI-DI 05060630101497

HEB
10
510(k) clearances
11,919
Adverse events (13 deaths)
36
Recalls
95
Facilities

Description

MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)

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.

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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.