Generic Name: Home-use Far-infrared Blood Circulation-promoting Garments — Trade Names: (1) Relive Shirt Α — (2) Relive Spats Α

Recalling firm: Name of Manufacturer/Distributor: Relive Co., Ltd. — Address of Manufacturer/Distributor: 3-27-3 Chomegaoka, Izumi Ward, Sendai City, Miyagi Prefecture — License Type: Type III Medical Device...
Product: Lot: （１）リライブシャツα 対象ロット出荷数量最終出荷日 216 30151 2024/12/26(木) 226 49428 2025/7/10(木) 2410000003 29183 2025/10/8(水) 2410000070 30272 2025/10/9(木) 2410000094 10128 2025/10/22(水) 2411000031 9868 2025/10/20(月) 241212AZ07 18568 2025/10/24(金) 246 60752 2025/9/18(木) 2501000029 26617 2025/10/16(木) 250131AZ08 2590 2025/10/10(金) 256 54561 2025/10/20(月) H121 10714 2025/5/16(金) S241118061 22194 2025/10/2(木) （２）リライブスパッツα 対象ロット出荷数量最終出荷日 215 2979 2024/9/24(火) 219 11365 2025/4/18(金) 221 8564 2025/2/19(水) 233 2817 2025/2/19(水) 236 20202 2025/8/19(火) 2411000024 1684 2025/10/9(木) 2412000002 9131 2025/10/17(金)...
Reason: Regarding home-use far-infrared blood circulation-promoting garments, the Q&A document dated August 18, 2025, clearly states that the definition does not apply to “products that do not have the function of emitting far-infrared rays across the entire garment, but rather products that emit far-infrared rays only from a specific part of the garment, or products to which prints or stickers with such functionality have been partially applied.” We have determined that our “Relive Shirt α” and “Relive Spats α” do not meet the definition of “home-use far-infrared blood circulation-promoting...
Classification: Class III
Category: medical device recall
Country: Japan
Agency: PMDA-DEVICE
Status: Ongoing

Recall details on Nibble Recalls: https://trynibble.app/recalls/3cb3cc34-5147-4a05-a112-c55c8fb3743f