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ROSE
ORGENICA O.A.A LTD · Model Cardboard applicator, Regular · UDI-DI 07290019338024
10
510(k) clearances
11,865
Adverse events (13 deaths)
36
Recalls
95
Facilities
Description
Organic Cotton Cardboard Applicator tampons, Regular, 16u
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.