thejoe DAYE (ANNE'S DAY LTD)

DAYE (ANNE'S DAY LTD): 29 FDA recall reports

Every medical device recall the FDA has published for DAYE (ANNE'S DAY LTD). The fault, and how the agency graded it.

29Reports

0Class I

29Ongoing

2025-11-05Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	29

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;

Z-0396-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;

Z-0393-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Where it went: US Nationwide distribution.
How much: 3074 packs

9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;

Z-0379-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;

Z-0397-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Where it went: US Nationwide distribution.
How much: 3074 packs

18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;

Z-0381-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;

Z-0399-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Where it went: US Nationwide distribution.
How much: 3074 packs

9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;

Z-0385-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

Z-0404-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;

Z-0405-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;

Z-0400-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Trial Tampon Box; Model Number: FG-TMP-REF04050504;

Z-0386-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;

Z-0406-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Where it went: US Nationwide distribution.
How much: 3074 packs

Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;

Z-0389-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;

Z-0394-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;

Z-0398-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;

Z-0391-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;

Z-0407-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;

Z-0401-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

Z-0402-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Where it went: US Nationwide distribution.
How much: 3074 packs

18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

Z-0382-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;

Z-0388-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Where it went: US Nationwide distribution.
How much: 3074 packs

9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;

Z-0384-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;

Z-0390-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;

Z-0395-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
Where it went: US Nationwide distribution.
How much: 3074 packs

All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;

Z-0387-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Where it went: US Nationwide distribution.
How much: 3074 packs

9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;

Z-0383-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;

Z-0403-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
Where it went: US Nationwide distribution.
How much: 3074 packs

9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;

Z-0380-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: 9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
Where it went: US Nationwide distribution.
How much: 3074 packs

Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;

Z-0392-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Product lacks 510(k) clearance.
Product: Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Where it went: US Nationwide distribution.
How much: 3074 packs

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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