Generic Name: Single-use Endoscopic Snare For Electrosurgery — Trade Name: Disposable Endoscopic Snare
Recall Summary Steris Japan is recalling specific lots of disposable endoscopic snares (medical devices used to remove tissue and polyps during endoscopy procedures) because the label incorrectly states the quantity of items in the package. The device itself functions properly and poses no safety risk; no injuries have been reported. This recall affects 86 boxes shipped on July 7, 2025, with lot numbers 12243006 and 12364287.
- Recalling firm
- Name of Manufacturer and Distributor: Steris Japan Co., Ltd. — Address of Manufacturer and Distributor: QV1 Kojimachi, 1-5 Kojimachi, Chiyoda-ku, Tokyo — Type of License: Type II Medical Device...
- Product
- Lot: 対象ロット：12243006/12364287 数量：86箱 出荷時期：2025年7月7日. Use: 高周波電流を利用して組織及びポリープを焼灼、切除する内視鏡用スネアである。高周波電流を使用せずに組織 及びポリープを機械的に切除することもできる。. Health hazards: 本件は薬事ラベルにおける「入り数」の誤表示であり、医療機器自体の品質、有効性及び安全性に影響を及ぼす ことはなく、健康被害を引き起こす可能性はないと考える。 また、現在までに本件に関わる健康被害の発生報告はない。
- Reason
- This is because it was discovered that the "quantity per package" listed on the pharmaceutical label affixed to the product's individual packaging was incorrectly stated.
- Classification
- Class III
- 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/1ceb6515-200d-4553-8118-8a7c1f6b8c87