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H-E-B
H. E. BUTT GROCERY COMPANY · Model 100% Cotton Tampons Multipack · UDI-DI 00041220410279
10
510(k) clearances
11,919
Adverse events (13 deaths)
36
Recalls
96
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 (12+12) offered in two absorbencies: Regular and Super. Each tampon is registered in GUDID database with a different Primary DI Number: - 100% Cotton Tampons Regular: 00041220410224 - 100% Cotton Tampons Super: 00041220410262
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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Get your free API keyRead the docsData 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.