Rael Organic Cotton Tampons: Regular Absorbancy
RAEL INC · Model RAEL-TP-RG-01 · UDI-DI 00856032008442
1
510(k) clearances
11,919
Adverse events (13 deaths)
36
Recalls
95
Facilities
Description
A traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbencies: Regular and Super.
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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