[pending] Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Pending LLM rewrite. Source: FDA_DEVICE Z-0392-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product lacks 510(k) clearance.
The recalled product
- Product
- Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
- Manufacturer
- DAYE (ANNE'S DAY LTD)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: FG-TMP-MM-REF18180000
- UDI-DI: 5060994741216
- Lot numbers: 20CR0014
- 20CS0034
- 20CS0037
- 20CS0038
- 20CS0039
- 20CS0040
- 20CS0041
- CR001597
- CR001598
- CR001599
- CR001616
- CR001616NR001893
- CR001617
- CR001617CS002165
- CR001617NR001844ST23/R/3001-0523ADL
- CR001617NR001902
- CR001619
- CR001623
Distribution
Distributed nationwide across the United States.
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