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CVS Pharmacy Inc.

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Model Mix Tampons CVS · UDI-DI 00050428573181

HEB

510(k) clearances

11,919

Adverse events (13 deaths)

Recalls

Facilities

Description

The device will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The box contains two types of tampons (18+18) offered in two absorbencies: Regular and Super. Each tampon is individually wrapped with two different color and packaged in multi -unit containers for retail sale. Regular (green wrapper) and Super (pink wrapper). Each tampon is registered in GUDID database with a different Primary DI Number: - Applicator Regular : 00050428516706 - Applicator Super : 00050428513279

Recalls

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