Generic Name: Home Air Massager — Product Name: Doctor Medmar Dm-4s
Recall Summary The Doctor Medmar DM-4S home air massager is being recalled due to a defect in Boot A's air intake port (pink), which can separate from its weld during use. When this happens, air leaks from the boot and causes the device to stop with an error instead of reaching its intended pressure setting. No serious health injuries have been reported so far, and the manufacturer does not expect any severe health risks from this issue.
- Recalling firm
- Name of Manufacturer/Distributor: Nitto Koki Co., Ltd. — Address of Manufacturer/Distributor: 2-9-4 Nakaikegami, Ota-ku, Tokyo — Type of License: Type II Medical Device Manufacturer/Distributor —...
- Product
- Lot: 型式：DM-4S(B)-A7073-A1-0002 50210261〜50210310、50210312〜50210315、50210317〜50210360 出荷数量：98台 出荷期間：令和7年4月22日〜令和7年5月14日. Use: あんま、マッサージの代用。一般家庭で使用する。. Health hazards: ブーツＡ第1気室空気取り入れ口（ピンク）の溶着が剥離することにより、ブーツＡ内の空気が漏れ 圧力が設定値に到達せずにエラー停止するため、重篤な健康被害発生の恐れはないと考えます。 尚、これまでに健康被害の報告は受けておりません。
- Reason
- We have confirmed instances where the air intake port (pink) in the first chamber of Boot A, an accessory for a specific lot of this product, has delaminated from the weld after a short period of use. Therefore, we are conducting a recall to replace Boot A.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/dc7e14ef-b5af-43cd-9a53-33c19b81c0d4