Generic Name: Japanese Pharmacopoeia Carbon Dioxide Trade Name: Japanese Pharmacopoeia Carbon Dioxide
Recall Summary Medical-grade carbon dioxide cylinders from Koike Oxygen Industries (Lot 1251209, shipped December 10, 2025) are being recalled because one cylinder was overfilled and had higher-than-normal pressure when a regulator was attached. The overfilled cylinder weighed 8.5 kg more than it should have. These cylinders are used in medical settings for respiratory stimulation, anesthesia, laparoscopic surgery, and imaging procedures. No injuries have been reported, and a pressure regulator is used during normal medical application, which prevents pressure-related harm.
- Recalling firm
- Name of Manufacturer and Distributor: Koike Oxygen Industries Co., Ltd. Address of Manufacturer and Distributor: 9-1-1 Oshima, Koto-ku, Tokyo Type of License: Type II Pharmaceutical Manufacturing...
- Product
- Lot: 対象ロット：1251209 数量 ：13本 対象容器 ：4X66702,3PEI30882,CFD69643,1H19595,3PEI63770,PEI60268,PEI55051,PIEA48391 8H16786,3BIS30595,4J18894,GNK12818,QM42554 出荷時期 ：2025年12月10日. Use: 【効能・効果】 1）酸素吸入時の呼吸中枢の刺激 2）高山病における呼吸困難、麻酔時における覚せいと手術後の肺拡張不全の予防 3）一酸化炭素、モルヒネ、シアン化合物などの中毒時における呼吸中枢の興奮性低下 4）炭酸水の水浴による脈拍及び拡張期血圧の減少、静脈血の心臓還流の改善と拍出量の増加、皮膚の充血、呼 吸量の増加 5）ドライアイスでの狼瘡、色素斑などの皮膚疾患の腐食剤として使用 6）腹腔鏡下外科手術に必要な視野及び術野の確保 7）X線コンピュータ断層撮影に必要な腸管の拡張. Health hazards: 本品は出荷前に日本薬局方の規定に基づく医薬品の日本薬局方二酸化炭素の品質検査を行っており、品質に問題 のないことを確認しています。 本品を使用する際には減圧弁にて減圧して使用するため、圧力が高いことによる健康被害の恐れはありません。 現在まで本品による健康被害はございません。
- Reason
- The medical institution that received the delivery contacted the retailer, stating, “When we attached a pressure regulator to this medical carbon dioxide cylinder and opened the valve, the pressure seemed higher than usual.” The retailer checked the pressure and recalled a total of two cylinders: the cylinder in question and another cylinder delivered at the same time. After the recall, the pressure of the medical carbon dioxide cylinder in question was checked at the Gunma General Gas Center, and a weight inspection revealed that it was 8.5 kg heavier than the proper fill weight. It was...
- Classification
- Class II
- Category
- drug recall
- Country
- Japan
- Agency
- PMDA-DRUG
- Recall date
- 2026-02-18
- Status
- Ongoing
Official recall notice from PMDA-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/c6247e5d-85f7-4196-bafb-7ece7f086b0d