Quality Risk from Product Defects and Recalls
First written in FY2016. 8 of 14 entries say "Materialised", first in FY2020. Latest entry: FY2026.
The whole theme swung hardest in 2026: 11 of 57 companies on the "Worse" side.
- FY2026MaterialisedAnnual report
「The cost ratio deteriorated due to the recognition of a provision of approximately ¥2,500 million for costs related to the voluntary recall of certain surgical devices.」
Regarding product quality risk, a voluntary recall of certain surgical devices occurred, resulting in the recognition of a provision of approximately ¥2,500 million. - 2026-05-12MaterialisedRevision of earnings forecasts
「The cost ratio deteriorated because approximately ¥2.4 billion in costs associated with the voluntary recall of certain surgical device products was recognized as a provision.」
Recognized a provision of approximately ¥2.4 billion for the voluntary recall of certain surgical device products. - FY2025MitigatedAnnual report
「The cost-of-sales ratio improved by 1.7 percentage points from the previous fiscal year to 31.4%, as the approximately ¥5,200 million in costs related to market corrective action for high-speed insufflators and approximately ¥5,000 million in costs related to the voluntary recall of small-bowel endoscopy systems and other products that had been provided for in the Endoscopic Solutions Business in the previous fiscal year no longer occurred.」
The market corrective-action and voluntary-recall costs recognized in the previous fiscal year did not recur in the current fiscal year, improving the cost-of-sales ratio. - FY2025-H1MitigatedAnnual report
「The cost-of-sales ratio improved by 2.0 percentage points year on year to 31.9%, as the approximately ¥5,000 million in costs related to the voluntary recall of small-bowel endoscopy systems and other products that had been provided for in the Endoscopic Solutions Business in the previous fiscal year no longer occurred.」
The approximately ¥5,000 million in costs related to the voluntary recall of small-bowel endoscopy systems and other products recognized in the previous fiscal year did not recur in the current fiscal year, improving the cost-of-sales ratio year on year. - FY2024MaterialisedAnnual report
「The cost-of-sales ratio deteriorated by 0.9 percentage points from the previous fiscal year to 33.2%, due to the recognition of provisions for approximately ¥5,200 million in costs related to market corrective action for high-speed insufflators in the Endoscopic Solutions Business and approximately ¥4,200 million in costs related to the voluntary recall of small-bowel endoscopy systems.」
Market corrective action for high-speed insufflators and a voluntary recall of small-bowel endoscopy systems occurred, resulting in the recognition of provisions for total costs of approximately ¥9,400 million. - FY2024-Q3MaterialisedAnnual report
「Following the results of a voluntary market investigation conducted by the Company, and based on its quality standards, the Company decided to voluntarily recall the applicable small-bowel endoscopy systems, with patient safety as its top priority. As the cost of this market action, the Company recognized a provision of ¥4,157 million in cost of sales of the Endoscopic Solutions Business for the nine months ended 31 December.」
The voluntary recall of small-bowel endoscopy systems was disclosed as an action taken, and a provision of ¥4,157 million was recognized. - FY2024-Q2MaterialisedAnnual report
「Following the results of a voluntary market investigation conducted by the Company, and based on its quality standards, the Company decided to voluntarily recall the applicable small-bowel endoscopy systems, with patient safety as its top priority. As the cost of this market action, the Company recognized a provision of ¥4,157 million in cost of sales of the Endoscopic Solutions Business for the six months ended 30 September.」
A voluntary recall of small-bowel endoscopy systems was newly decided, and a provision of ¥4,157 million was recognized. The risk of product defects and recalls became apparent as actual quality-related response costs. - FY2022MitigatedAnnual report
「In certain regions, the company had been collecting older products through trade-ins. During the fiscal year, it decided to exchange them for new products free of charge to accelerate progress, and because the amount deemed necessary for the market action changed, it reversed ¥2,663 million of the provision for product warranties.」
For the voluntary recall of bronchial video endoscopes and biliary fibroscopes, the company changed its response to free exchanges for new products and reversed the provision for product warranties. - FY2021MaterialisedAnnual report
「For the fiscal year, the Endoscopic Solutions Business recognized approximately ¥6,000 million in costs related to the voluntary recall of bronchoscopes and biliary endoscopes, while the Therapeutic Solutions Business recognized approximately ¥2,000 million in costs related to the voluntary recall of treatment devices.」
Voluntary recalls of bronchoscopes, biliary endoscopes and treatment devices actually occurred, resulting in the recognition of total costs of approximately ¥8,000 million. - FY2021-Q3Update to the voluntary recall provisionAnnual report
「As the cost of this market action, オリンパスメディカルシステムズ株式会社, the Company's manufacturing subsidiary with legal product liability, recognized a provision of ¥5,823 million in cost of sales of the Endoscopic Solutions Business for the nine months ended 31 December.」
The provision for the voluntary recall of bronchial video endoscopes and biliary fibroscopes was updated to ¥5,823 million for the nine months ended 31 December. - FY2021-Q2MaterialisedAnnual report
「Following the results of a voluntary market investigation conducted by the Company, and based on its quality standards, the Company decided to voluntarily recall the applicable bronchial video endoscopes and biliary fibroscopes, with patient safety as its top priority. As the cost of this market action, オリンパスメディカルシステムズ株式会社, the Company's manufacturing subsidiary with legal product liability, recognized a provision of ¥6,044 million in cost of sales of the Endoscopic Solutions Business for the six months ended 30 September.」
A voluntary recall of bronchial video endoscopes and biliary fibroscopes was newly decided, and a provision of ¥6,044 million was recognized. - FY2020MaterialisedAnnual report
「The company reasonably estimates the amount deemed necessary for this market action and recognizes it as a provision.」
In connection with quality risks such as product defects and recalls, a voluntary market action was conducted for duodenoscopes, and a provision of ¥12,000 million was recognized. - FY2018RestatedAnnual report
「The Group manufactures products under strict quality standards, including at external contract manufacturers. If a product defect or other issue were to occur, this could result not only in substantial costs such as recalls, but also damage the Group's reputation and affect its ability to secure revenue.」
The company reiterates the potential impact of product defects and recalls on costs and credibility. - FY2016First statedAnnual report
「The Group manufactures products under strict quality standards, including at external contract manufacturers. If a product defect or other issue were to occur, this could result not only in substantial costs such as recalls, but also damage the Group's reputation and affect its ability to secure revenue.」
This is disclosed together with the development of quality standards, the quality assurance framework and the company-wide quality management system.