Safety Recall: Makichie Tinnitus Masker Tinitrea SG – Japan CAA

Published by Reclia Safety Desk | June 29, 2026

Recall Information Record

Case Number: 00000035371
Product: Tinnitus Masker Tinitrea SG
Brand: Makichie
Hazards: Safety Risk
Source: Japan Consumer Affairs Agency (CAA)

WHAT HAPPENED

Makichie has announced a recall for its ‘Tinitrea SG’ tinnitus masker (product name: 耳鳴マスカ ティニトレアSG). The recall was registered with the Japan Consumer Affairs Agency under management number 00000035371 and is also referenced by the Pharmaceuticals and Medical Devices Agency (PMDA). The issue involves a packaging error where the instruction manual for a different variant (‘Tinitrea SG’ without model number) was included instead of the correct manual for the ‘Tinitrea SG TS5-SG’ model.

This mispackaging could lead to improper use or maintenance of the device, potentially affecting user safety or treatment efficacy. As a medical device, correct instructions are critical for safe operation. The recall start date is set for June 2, 2026, and consumers who have purchased the affected product are urged to verify the manual they received.

If you own a ‘Tinitrea SG’ tinnitus masker, please take the following steps:

• Check the instruction manual included with your device. If it does not explicitly state ‘TS5-SG’ on the cover or title page, it may be the incorrect manual.
• Contact Makichie customer support using the information provided on the recall notice to request the correct manual for the ‘Tinitrea SG TS5-SG’ model.
• Do not dispose of the device; the recall is for the manual only, not the product itself. Follow any further instructions from the manufacturer.

AFFECTED BATCHES & TARGET SPECIFICS

– **Target Model / Type:** N/A
– **JAN Barcode:** N/A
– **Affected Serial / Lot Numbers:** N/A
– **Total Units Affected:** N/A

ADDITIONAL REGULATORY NOTES

The recall notice (management number 00000035371) was issued by the Japan Consumer Affairs Agency (CAA). The product is a medical device (tinnitus masker) regulated by PMDA. The defect involves inclusion of an incorrect instruction manual: the manual for ‘Tinitrea SG (no model number)’ was packaged instead of the correct manual for ‘Tinitrea SG TS5-SG’. The recall start date is June 2, 2026.

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