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Don't Run Out, Inc. · Model 010-601-008-011 · UDI-DI 00810152230848

HEB
1
510(k) clearances
11,966
Adverse events (13 deaths)
36
Recalls
97
Facilities

Description

Cotton Tampons with Cardboard Applicator - Regular 16ct

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.