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

US Nationwide distribution.

DAYE (ANNE'S DAY LTD), London, N/A, United Kingdom.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Device events that started in 2025

945

Share of these events in Class II

85%

Product records in this event

29

Events of the firm on the register

1

• FDA enforcement report Z-0379-2026The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Where was the product distributed?

The FDA record gives this distribution: US Nationwide distribution.

What quantity of product is in FDA event 97718?

The event has 29 product records. The first record gives this quantity: 3074 packs

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many device recalls of 2025 have the same class?

85% of the 945 device events that started in 2025 are in Class II.