Japan Pharma Regulatory Brief

Japan · Quality & recalls · 医薬品等の回収情報

Japan Drug & Device Recalls (in English, updated weekly)

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

636recalls posted by PMDA in the 12 months to September 2026
74Class I recalls (serious risk) in those 12 months
42recalls in the latest 4 weeks (2026-08-29 to 2026-09-25), listed below
55Japanese recalls with a possible US FDA recall (same ingredient or firm, ±12 months)

Latest recalls in Japan (last 4 weeks)

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; = no English yet. Each row links to PMDA, where lots, quantities and contacts are listed.

DateClass CategoryProduct (EN / JA)Company (MAH) Reason (short)Source
2026-09-25Class IIMedical deviceSenographe 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
2026-09-25Class IIMedical deviceCareLink 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
2026-09-18Class IIIMedical deviceCirri 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
2026-09-18Class IIICosmetic
化粧品		リッカジェル アイアンサンドジェル FE00 株式会社ソーカル English summary pending — see PMDA
Other		PMDA
2026-09-18Class IICosmetic
化粧品		オイルLa 株式会社ミューズ研究所 English summary pending — see PMDA
Labeling error		PMDA
2026-09-18Class IIDrugLevofloxacin 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
2026-09-18Class IIQuasi-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
2026-09-17Class IIICosmetic
化粧品		AUS ネイルオイル ARG 株式会社ビー・エヌ English summary pending — see PMDA
Other		PMDA
2026-09-17Class IICosmetic
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 ロク株式会社 English summary pending — see PMDA
Labeling error		PMDA
2026-09-17Class IIMedical deviceOmniaSecure 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
2026-09-17Class IIMedical deviceHLS 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
2026-09-16Class IIMedical deviceDirection 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
2026-09-16Class IIIn-vitro diagnosticVitek 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
2026-09-15Class IIMedical deviceHoffmann 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
2026-09-15Class IIMedical deviceT-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
2026-09-14Class IIMedical devicePorges 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
2026-09-11Class IIMedical deviceAXIS (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
2026-09-11Class IICosmetic
化粧品		モイストエマルジョンHO / モイストローションHO 松山油脂株式会社 English summary pending — see PMDA
Other		PMDA
2026-09-10Class IIMedical devicePancreatic 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
2026-09-10Class IIMedical deviceNav 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
2026-09-08Class IIMedical deviceVersiFlex 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
2026-09-07Class IIICosmetic
化粧品		イーザーアンドマルチグリームバー 株式会社DirectTech English summary pending — see PMDA
Labeling error		PMDA
2026-09-07Class IIIMedical deviceOLYMPUS 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
2026-09-07Class IIMedical deviceAzurion (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
2026-09-07Class IIDrugHifdula 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
2026-09-07Class IIDrugBetamethasone 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
2026-09-07Class IIMedical deviceInvictus 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
2026-09-07Class IIMedical deviceBone 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
2026-09-07Class IIMedical deviceHLC-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
2026-09-07Class IDrugFresh 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
2026-09-04Class IIIn-vitro diagnosticHemosAI 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
2026-09-03Class IIMedical deviceGore 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
2026-09-03Class IIMedical deviceNeuroStar (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
2026-09-02Class IIMedical devicePhilips 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
2026-09-02Class IDrugFresh 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
2026-09-01Class IIIMedical deviceHI-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
2026-09-01Class IIDrugSodium 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
2026-09-01Class IIDrugYM 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
2026-09-01Class IICosmetic
化粧品		TP リッププランパー 02 株式会社ドゥ・ベスト English summary pending — see PMDA
Contamination / foreign matter		PMDA
2026-08-31Class IIICosmetic
化粧品		BELA VELAブースターソープ 有限会社ながれま English summary pending — see PMDA
Labeling error		PMDA
2026-08-31Class IIMedical deviceIMPELLA 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
2026-08-31Class IIDrugMovicol 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

Was it recalled in the US too? (FDA enforcement reports)

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 dateJP classJapanese recallUS FDA recall (enforcement report)Match
2026-09-02Class IIPhilips 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
2026-08-31Class IIIMPELLA 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
2026-08-24Class IIBECKMAN 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

Recalls per month by class

MonthClass IClass IIClass IIITotal
September 2026231639
drug 7 · device 22 · IVD 2 · other 8
August 20264281446
drug 9 · device 15 · IVD 13 · other 9
July 2026546859
drug 16 · device 32 · IVD 6 · other 5
June 20261544968
drug 24 · device 33 · IVD 3 · other 8
May 2026442854
drug 7 · device 35 · IVD 1 · other 11
April 2026647558
drug 14 · device 30 · IVD 3 · other 11
March 2026532643
drug 8 · device 29 · IVD 1 · other 5
February 20265481063
drug 16 · device 34 · IVD 1 · other 12
January 2026531844
drug 7 · device 22 · IVD 5 · other 10
December 2025834951
drug 12 · device 28 · IVD 1 · other 10
November 2025736750
drug 17 · device 24 · IVD 2 · other 7
October 2025846761
drug 19 · device 35 · IVD 3 · other 4

Download: monthly counts by class and category (CSV, aggregated, 24 months).

By category and class (last 12 months)

CategoryRecallsShare
Drug15625%
Medical device33953%
In-vitro diagnostic416%
Other10016%
ClassRecallsShare
Class I7412%
Class II46573%
Class III9715%

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.

Why products are recalled in Japan (last 12 months)

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 categoryRecallsShareClass I
Device malfunction14222%1
Labeling error12920%
Other11318%49
Out of specification / stability7011%
Contamination / foreign matter295%
GMP / data integrity254%1
Sterility244%
Nitrosamine impurity10%
Reason not in our data yet (older, completed recall)10316%23

Earlier recalls (counts only)

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.

What the subscriber edition adds

  • Every recall, every week in the Friday email: class, product, company, our English summary of the reason, and whether a foreign site is mentioned, each linked to the PMDA notice.
  • The full Japan → US match table: every candidate FDA enforcement report, its class, reason and number.
  • Archive and CSV of all recalls since April 2024, and alerts for the ingredients, companies or device types you watch.

Join the free weekly email now for the headlines. Sign up free ↓

How recalls work in Japan (回収とクラス分類)

Japanese recall classes (クラス分類)

Class I
Use of (or exposure to) the product may cause serious adverse health consequences or death.
その製品の使用等が、重篤な健康被害又は死亡の原因となり得る状況
Class II
Use of the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
その製品の使用等が、一時的な若しくは医学的に治癒可能な健康被害の原因となる可能性がある状況又はその製品の使用等による重篤な健康被害のおそれはまず考えられない状況
Class III
Use of the product is unlikely to cause adverse health consequences.
その製品の使用等が、健康被害の原因となるとはまず考えられない状況

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.

Methodology

Sources & attribution

  • Source: Pharmaceuticals and Medical Devices Agency (PMDA) website (https://www.pmda.go.jp/), PDL1.0: “医薬品等の回収に関する情報” (drugs, devices; lists at https://www.info.pmda.go.jp/kaisyuu/). Created by editing and translating these materials. The recall summaries are written by each marketing authorisation holder; we show only facts (date, class, category, product, company) and our own short English summary of the reason. Lots, quantities, contacts and the full notice are on PMDA's page for each recall. PMDA's recall pages state: “自ら所属する医療機関、薬局等において使用することを目的とする場合を除き、本情報の内容を情報提供者に無断で複製、転載、頒布する等の行為を禁じます。” (the content may not be copied, reproduced or distributed without the permission of the information provider, i.e. the company). We therefore do not copy the notices; please use the PMDA link for the original.
  • Class definitions: Ministry of Health, Labour and Welfare (MHLW) notice on recalls of drugs and medical devices (MHLW legal database), PDL1.0; the English wording is ours.
  • US match: data provided by the U.S. Food and Drug Administration (https://open.fda.gov; openFDA drug and device enforcement reports). Public domain. Not endorsed by FDA; openFDA data is not for clinical use.

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.

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