Japan · Quality & recalls · 医薬品等の回収情報
Every recall PMDA posts for drugs, medical devices and diagnostics — class, product, company and reason in English, with a check for a matching US FDA recall. How Japanese recall classes work ↓
Last updated: 2026-09-27 · latest recall 2026-09-25 · source: PMDA (PDL1.0), edited and translated · US: openFDA enforcement reports
42 recalls posted from 2026-08-29 to 2026-09-25, newest first. “Reason (short)” is our one-line English summary of the company's notice; the grey line is our reason category. * = AI translation, not yet checked by hand; JP = no English yet. Each row links to PMDA, where lots, quantities and contacts are listed.
| Date | Class | Category | Product (EN / JA) | Company (MAH) | Reason (short) | Source |
|---|---|---|---|---|---|---|
| 2026-09-25 | Class II | Medical device | Senographe Pristina (digital mammography X-ray diagnostic system)* 乳房用X線診断装置 Senographe Pristina 据置型デジタル式乳房用X線診断装置 | GE Healthcare Japan Co., Ltd.* GEヘルスケア・ジャパン株式会社 | In 3D+2D manual mode, when anode/filter combinations differ between 2D and 3D imaging, collimator settings may not be properly configured;* Device malfunction | PMDA |
| 2026-09-25 | Class II | Medical device | CareLink SmartSync Device Manager (implantable device programmer)* ケアリンク SmartSync Device Manager 植込み能動型機器用プログラマ | Medtronic Japan, Ltd.* 日本メドトロニック株式会社 | Under specific conditions, the predicted battery life displayed by the 'Micra VR2 AV2 application D00U022' may be displayed inaccurately;* Device malfunction | PMDA |
| 2026-09-18 | Class III | Medical device | Cirri Nasal Mask Mini (artificial ventilation mask)* Cirri ネーザルマスク ミニ 人工呼吸器用マスク | Iwaki Co., Ltd.* イワキ株式会社 | Products with labeling for a different product were inadvertently mixed into the target lot.* Labeling error | PMDA |
| 2026-09-18 | Class III | Cosmetic 化粧品 | リッカジェル アイアンサンドジェル FE00 JP | 株式会社ソーカル JP | English summary pending — see PMDA Other | PMDA |
| 2026-09-18 | Class II | Cosmetic 化粧品 | オイルLa JP | 株式会社ミューズ研究所 JP | English summary pending — see PMDA Labeling error | PMDA |
| 2026-09-18 | Class II | Drug | Levofloxacin 250mg tablets* レボフロキサシン錠250mg「TCK」 Levofloxacin hydrate | Tatsumi Chemical Co., Ltd.* 辰巳化学株式会社 | Stability monitoring at 12 months for Lot KFDZ showed out-of-specification dissolution results;* Out of specification / stability | PMDA |
| 2026-09-18 | Class II | Quasi-drug 医薬部外品 | Yakult BL Chewable Intestinal Regulator* ヤクルトBLチュアブル整腸薬 | Yakult Co., Ltd.* 株式会社ヤクルト | Stability monitoring revealed that active ingredient content in certain lots may fall below specifications before expiration.* Out of specification / stability | PMDA |
| 2026-09-17 | Class III | Cosmetic 化粧品 | AUS ネイルオイル ARG JP | 株式会社ビー・エヌ JP | English summary pending — see PMDA Other | PMDA |
| 2026-09-17 | Class II | Cosmetic 化粧品 | 6oku セルビューティーローションAL / 6oku セルビューティーローションAV / 6oku セルビューティーローションBE / 6oku セルビューティーローションSA / 6oku セルビューティーローションTA / 6oku セルビューティーローションYA JP | ロク株式会社 JP | English summary pending — see PMDA Labeling error | PMDA |
| 2026-09-17 | Class II | Medical device | OmniaSecure MRI Lead (implantable defibrillator/pacemaker lead)* OmniaSecure MRIリード 植込み型除細動器・ペースメーカリード | Medtronic Japan, Ltd.* 日本メドトロニック株式会社 | Five cases of implantation difficulties were reported globally for certain lots;* Device malfunction | PMDA |
| 2026-09-17 | Class II | Medical device | HLS Cannula (heparin-coated central circulatory arteriovenous cannula)* HLS カニューレ ヘパリン使用中心循環系動静脈カニューレ | Getinge Group Japan Co., Ltd.* ゲティンゲグループ・ジャパン株式会社 | Sterilization barrier integrity verification testing identified failed cases;* Sterility | PMDA |
| 2026-09-16 | Class II | Medical device | Direction Catheter System (central circulatory microcatheter)* ディレクション カテーテルシステム 中心循環系マイクロカテーテル | Boston Scientific Japan Co., Ltd.* ボストン・サイエンティフィックジャパン株式会社 | Manufacturing defects in certain lots may cause difficulty in withdrawing the product from the protective sheath or inserting/withdrawing through the…* Device malfunction | PMDA |
| 2026-09-16 | Class II | In-vitro diagnostic | Vitek 2 Yeast-Like Fungi Susceptibility Card (antifungal susceptibility test kit)* バイテック 2 酵母様真菌感受性カード 薬剤感受性(真菌)キット | bioMérieux Japan Co., Ltd.* ビオメリュー・ジャパン株式会社 | Target lots may produce falsely elevated (false-resistant) results in amphotericin B susceptibility testing.* Device malfunction | PMDA |
| 2026-09-15 | Class II | Medical device | Hoffmann 3 External Fixation System (external fixator)* ホフマン3創外固定システム 創外固定器 | Stryker Japan Co., Ltd.* 日本ストライカー株式会社 | Surface discoloration from non-uniform Ni PTFE coating results in out-of-specification coating thickness and color, which may accelerate degradation…* Out of specification / stability | PMDA |
| 2026-09-15 | Class II | Medical device | T-FLEX Anesthesia/Respiratory Circuit Set (anesthesia circuit set)* T-FLEX 麻酔/呼吸 回路セット 麻酔回路セット | Total Medical Supply Co., Ltd.* 株式会社トータルメディカルサプライ | Inner tube separation was confirmed in the target lot;* Device malfunction | PMDA |
| 2026-09-14 | Class II | Medical device | Porges Ureteral Stent (long-term ureteral tube stent)* ポルジェス 尿管ステント 長期使用尿管用チューブステント | Coloplast Co., Ltd.* コロプラスト株式会社 | The Japanese label on the product box displayed the outer diameter (4.8Fr/1.6mm) instead of the actual specification (6Fr/2mm).* Labeling error | PMDA |
| 2026-09-11 | Class II | Medical device | AXIS (anesthesia system)* エイシス 麻酔システム | GE Healthcare Japan Co., Ltd.* GEヘルスケア・ジャパン株式会社 | Flow sensor signal abnormalities in the electronic gas mixer assembly may cause unintended switching to backup O2 control, interrupting anesthetic…* Device malfunction | PMDA |
| 2026-09-11 | Class II | Cosmetic 化粧品 | モイストエマルジョンHO / モイストローションHO JP | 松山油脂株式会社 JP | English summary pending — see PMDA Other | PMDA |
| 2026-09-10 | Class II | Medical device | Pancreatic Plastic Stent System (pancreatic stent)* 膵管用プラスチックステントシステム 膵臓用ステント | Boston Scientific Japan Co., Ltd.* ボストン・サイエンティフィックジャパン株式会社 | Certain lots were incorrectly manufactured with an unintended guide wire port not present in the original product specifications.* Device malfunction | PMDA |
| 2026-09-10 | Class II | Medical device | Nav Instrument (bone surgical instrument) / Passive Biopsy Needle (single-use tissue biopsy needle)* Navインスツルメント / パッシブバイオプシーニードル (1)骨手術用器械、(2)単回使用組織生検用針 | Medtronic Japan, Ltd.* 日本メドトロニック株式会社 | Reflective ball coating variance in certain lots may compromise compatibility with optical navigation and robotic-guided systems.* Device malfunction | PMDA |
| 2026-09-08 | Class II | Medical device | VersiFlex VISTA (stationary digital multipurpose X-ray fluoroscopy diagnostic system)* 多目的イメージングシステム VersiFlex VISTA 据置型デジタル式汎用X線透視診断装置 | Fujifilm Corporation* 富士フイルム株式会社 | Electronic components in the X-ray collimator control board may fail;* Device malfunction | PMDA |
| 2026-09-07 | Class III | Cosmetic 化粧品 | イーザーアンドマルチグリームバー JP | 株式会社DirectTech JP | English summary pending — see PMDA Labeling error | PMDA |
| 2026-09-07 | Class III | Medical device | OLYMPUS CF-XZ1200 series (video flexible colonoscope)* 大腸ビデオスコープ OLYMPUS CF-XZ1200 シリーズ ビデオ軟性大腸鏡 | Olympus Medical Systems Corp.* オリンパスメディカルシステムズ株式会社 | The product label contains incorrect common name and product name designations.* Labeling error | PMDA |
| 2026-09-07 | Class II | Medical device | Azurion (stationary digital circulatory X-ray fluoroscopy diagnostic system)* 血管造影X線診断装置 Azurion 据置型デジタル式循環器用X線透視診断装置 | Philips Japan Co., Ltd.* 株式会社フィリップス・ジャパン | The Float Tabletop control may experience peeling, cracking, or breakage due to mechanical wear, resulting in restricted movement and potential sharp…* Device malfunction | PMDA |
| 2026-09-07 | Class II | Drug | Hifdula combination subcutaneous injection* ヒフデュラ配合皮下注 | Algernix Japan Co., Ltd.* アルジェニクスジャパン株式会社 | Foreign matter was found in one unopened vial in an overseas distributed lot, attributed to the rubber stopper.* Contamination / foreign matter | PMDA |
| 2026-09-07 | Class II | Drug | Betamethasone 0.5 mg tablets "Sawai"* ベタメタゾン錠0.5mg「サワイ」 Betamethasone | Sawai Pharmaceutical Co., Ltd.* 沢井製薬株式会社 | Stability monitoring showed non-conforming dissolution results in certain lots.* Out of specification / stability | PMDA |
| 2026-09-07 | Class II | Medical device | Invictus System (spinal internal fixation device)* Invictusシステム 脊椎内固定器具 | ATEC Japan Co., Ltd.* ATEC Japan株式会社 | Air leakage was reported from the threaded section of the packaging;* Sterility | PMDA |
| 2026-09-07 | Class II | Medical device | Bone Cement Mixing System (orthopedic bone cement mixer)* 骨セメントミキシングシステム 整形外科用骨セメント混合器 | Nakashima Health Force Co., Ltd.* ナカシマヘルスフォース株式会社 | Endotoxin concentration in target products may exceed the reference standard.* Sterility | PMDA |
| 2026-09-07 | Class II | Medical device | HLC-723GR01 (glycated hemoglobin analyzer)* 東ソー自動グリコヘモグロビン分析計 HLC‐723GR01 グリコヘモグロビン分析装置 | Tosoh Corporation* 東ソー株式会社 | The dilution unit component has insufficient pressure-resistant strength, which can prevent continued measurements if the unit malfunctions.* Device malfunction | PMDA |
| 2026-09-07 | Class I | Drug | Fresh frozen plasma-LR "Japanese Red Cross" 480 mL* 新鮮凍結血漿‐LR「日赤」480 Fresh frozen human plasma | Japanese Red Cross Society* 日本赤十字社 | A blood donor tested positive on infectious disease screening after donation;* Other | PMDA |
| 2026-09-04 | Class II | In-vitro diagnostic | HemosAI Accustar HIT-IgG(PF4-H) (HIT antibody immunoassay)* ヒーモスアイエル アキュスター HITーIgG(PF4ーH) クラスII免疫検査用シリーズ | A.L. Japan Co., Ltd.* アイ・エル・ジャパン株式会社 | Manufacturer investigation found potential negative bias in measurement results that could lead to false-negative HIT diagnosis and affect clinical…* Device malfunction | PMDA |
| 2026-09-03 | Class II | Medical device | Gore Viabahn stent graft (heparin-bonded stent graft)* ゴア バイアバーン ステントグラフト ヘパリン使用中心循環系ステントグラフト | W.L. Gore & Associates Japan LLC* 日本ゴア合同会社 | Manufacturing equipment malfunction may have caused misalignment of the delivery catheter tip joint position, potentially resulting in tip…* Device malfunction | PMDA |
| 2026-09-03 | Class II | Medical device | NeuroStar (transcranial magnetic stimulation therapy device)* NeuroStar TMS治療装置 経頭蓋治療用磁気刺激装置 | Vorpal Technologies Co., Ltd.* ヴォーパル・テクノロジーズ株式会社 | The coil-to-console cable in the HP coil assembly (product number 81-01000-201) does not conform to manufacturer specifications.* Device malfunction | PMDA |
| 2026-09-02 | Class II | Medical device | Philips Information Center (central monitor software)* セントラルモニタ フィリップスインフォメーションセンタ 解析機能付きセントラルモニタ用プログラム | Philips Japan Co., Ltd.* 株式会社フィリップス・ジャパン | Version 4.6.1 and earlier have a potential watchdog function malfunction that can cause system freeze and prevent alarm generation and recording.* Device malfunction | PMDA |
| 2026-09-02 | Class I | Drug | Fresh frozen plasma-LR "Japanese Red Cross" 240 mL* 新鮮凍結血漿‐LR「日赤」240 Fresh frozen human plasma | Japanese Red Cross Society* 日本赤十字社 | A blood donor was identified as having a contraindication to blood donation after their donation;* Other | PMDA |
| 2026-09-01 | Class III | Medical device | HI-SANSO Portable αII (oxygen concentrator)* ハイサンソポータブルαII 酸素濃縮装置(呼吸同調式レギュレータ) | Teijin Pharma Limited* 帝人ファーマ株式会社 | Some units had incorrect UDI label references to electronic package inserts.* Labeling error | PMDA |
| 2026-09-01 | Class II | Drug | Sodium bicarbonate injection 7% PL "Isei"* 炭酸水素ナトリウム静注7%PL「イセイ」 sodium bicarbonate* | Coreasis Co., Ltd.* コーアイセイ株式会社 | The manufacturing facility's GMP compliance inspection application had procedural defects.* GMP / data integrity | PMDA |
| 2026-09-01 | Class II | Drug | YM powder "Isei"* YM散「イセイ」 | Coreasis Co., Ltd.* コーアイセイ株式会社 | The raw material manufacturing facility's GMP compliance inspection application had procedural defects.* GMP / data integrity | PMDA |
| 2026-09-01 | Class II | Cosmetic 化粧品 | TP リッププランパー 02 JP | 株式会社ドゥ・ベスト JP | English summary pending — see PMDA Contamination / foreign matter | PMDA |
| 2026-08-31 | Class III | Cosmetic 化粧品 | BELA VELAブースターソープ JP | 有限会社ながれま JP | English summary pending — see PMDA Labeling error | PMDA |
| 2026-08-31 | Class II | Medical device | IMPELLA control unit (circulatory support pump device)* IMPELLA 制御装置 循環補助用心内留置型ポンプカテーテル用制御装置 | Japan Abiomed Co., Ltd.* 日本アビオメッド株式会社 | Component damage in the purge transmitter slot can lead to improper transmitter mounting.* Device malfunction | PMDA |
| 2026-08-31 | Class II | Drug | Movicol LD / Movicol HD combination oral formulation* モビコール配合内用剤LD / モビコール配合内用剤HD polyethylene glycol 3350* | EA Pharma Co., Ltd.* EAファーマ株式会社 | Some product lots contained non-uniformly distributed inorganic salts within the electrolyte composition.* Contamination / foreign matter | PMDA |
For each Japanese drug, IVD and device recall we search openFDA enforcement reports for a US recall of the same active ingredient (drugs) or the same firm with overlapping product words (devices), within 12 months either side. 55 of 1564 Japanese drug/IVD/device recalls in the dataset have at least one candidate. Three examples: A match is a lead to check, not proof of the same cause or lot.
| JP date | JP class | Japanese recall | US FDA recall (enforcement report) | Match |
|---|---|---|---|---|
| 2026-09-02 | Class II | Philips Information Center (central monitor software)* セントラルモニタ フィリップスインフォメーションセンタ 解析機能付きセントラルモニタ用プログラム Philips Japan Co., Ltd. | Z-3043-2026 Class II, 2026-08-07 Philips North America Llc + 4 more US recalls | high |
| 2026-08-31 | Class II | IMPELLA control unit (circulatory support pump device)* IMPELLA 制御装置 循環補助用心内留置型ポンプカテーテル用制御装置 Japan Abiomed Co., Ltd. | Z-2682-2026 Class I, 2026-06-11 Abiomed, Inc. + 4 more US recalls | high |
| 2026-08-24 | Class II | BECKMAN COULTER AU480 (Discrete Clinical Chemistry Analyzer)* 自動分析装置 BECKMAN COULTER AU480 ディスクリート方式臨床化学自動分析装置 Beckman Coulter Co., Ltd. | Z-2974-2026 Class II, 2026-07-15 Beckman Coulter Inc. + 4 more US recalls | high |
| + 52 more Japanese recalls with a possible US FDA recall — every match, the FDA reason text and the enforcement-report number: subscriber edition | ||||
| Month | Class I | Class II | Class III | Total | |
|---|---|---|---|---|---|
| September 2026 | 2 | 31 | 6 | 39 | drug 7 · device 22 · IVD 2 · other 8 |
| August 2026 | 4 | 28 | 14 | 46 | drug 9 · device 15 · IVD 13 · other 9 |
| July 2026 | 5 | 46 | 8 | 59 | drug 16 · device 32 · IVD 6 · other 5 |
| June 2026 | 15 | 44 | 9 | 68 | drug 24 · device 33 · IVD 3 · other 8 |
| May 2026 | 4 | 42 | 8 | 54 | drug 7 · device 35 · IVD 1 · other 11 |
| April 2026 | 6 | 47 | 5 | 58 | drug 14 · device 30 · IVD 3 · other 11 |
| March 2026 | 5 | 32 | 6 | 43 | drug 8 · device 29 · IVD 1 · other 5 |
| February 2026 | 5 | 48 | 10 | 63 | drug 16 · device 34 · IVD 1 · other 12 |
| January 2026 | 5 | 31 | 8 | 44 | drug 7 · device 22 · IVD 5 · other 10 |
| December 2025 | 8 | 34 | 9 | 51 | drug 12 · device 28 · IVD 1 · other 10 |
| November 2025 | 7 | 36 | 7 | 50 | drug 17 · device 24 · IVD 2 · other 7 |
| October 2025 | 8 | 46 | 7 | 61 | drug 19 · device 35 · IVD 3 · other 4 |
Download: monthly counts by class and category (CSV, aggregated, 24 months).
| Category | Recalls | Share |
|---|---|---|
| Drug | 156 | 25% |
| Medical device | 339 | 53% |
| In-vitro diagnostic | 41 | 6% |
| Other | 100 | 16% |
| Class | Recalls | Share |
|---|---|---|
| Class I | 74 | 12% |
| Class II | 465 | 73% |
| Class III | 97 | 15% |
73 of the 74 Class I recalls in the last 12 months were blood products of the Japanese Red Cross Society (日本赤十字社), typically after information received after donation.
Reason categories are ours, assigned from the company's Japanese text (keyword rules first, AI where the rules are unclear). Most common: Device malfunction. 106 recalls in the last 12 months mention a site outside Japan (import or foreign manufacturer).
| Reason category | Recalls | Share | Class I | |
|---|---|---|---|---|
| Device malfunction | 142 | 22% | 1 | |
| Labeling error | 129 | 20% | ||
| Other | 113 | 18% | 49 | |
| Out of specification / stability | 70 | 11% | ||
| Contamination / foreign matter | 29 | 5% | ||
| GMP / data integrity | 25 | 4% | 1 | |
| Sterility | 24 | 4% | ||
| Nitrosamine impurity | 1 | 0% | ||
| Reason not in our data yet (older, completed recall) | 103 | 16% | 23 |
Recalls posted before 2026-08-29 are shown as monthly counts by class. The full archive — every recall with product, company, reason summary and the US match — is in the subscriber edition.
Class definitions: MHLW notice 「医薬品・医療機器等の回収について」 (PFSB notice No. 1121-10, 21 Nov 2014; https://www.mhlw.go.jp/web/t_doc?dataId=00tc0581&;dataType=1&pageNo=1), as restated on PMDA's recall pages (https://www.pmda.go.jp/safety/info-services/drugs/calling-attention/recall-info/0002.html). English wording is our translation. Summary for orientation only; not regulatory advice.
出典：独立行政法人医薬品医療機器総合機構（PMDA）ウェブサイト「医薬品等の回収に関する情報」（https://www.pmda.go.jp/safety/info-services/drugs/calling-attention/recall-info/0002.html）を加工・翻訳して Japan Pharma Regulatory Brief が作成。回収の概要は各製造販売業者が作成したもの。クラス分類の定義は厚生労働省通知による。
Used under the Public Data License 1.0 (PDL1.0) (compatible with CC BY 4.0). The English text is an unofficial translation; the Japanese originals prevail. Not an official PMDA, MHLW or FDA list.
Last built: .