Risk of Medical Device Defects, Recalls and Litigation
First written in FY2016. 3 of 8 entries say "Materialised", first in FY2022-Q1. Latest entry: 2026-07-15.
The whole theme swung hardest in 2026: 11 of 57 companies on the "Worse" side.
- 2026-07-15MitigatedRevision of earnings forecasts
「The resale of diamond bars in China has been progressing above initial expectations, and strong performance has continued」
The resale of diamond bars following the voluntary recall in China is progressing above initial expectations, indicating that the sales impact associated with the recall has eased further. - FY2026-H1MitigatedAnnual report
「The company began the voluntary recall in March 2025 and had substantially completed it by August of the same year. After receiving approval from the Chinese regulatory authorities on 29 October 2025, it formally resumed sales in November of that year.」
The voluntary recall of the diamond burs in China was substantially completed by August 2025, and sales resumed in November of that year after approval from the regulatory authorities. - FY2025MaterialisedAnnual report
「Recall volume: 4.2 million units in the fiscal year ended [current fiscal year]... Sales decline due to voluntary recall: △1,481 million... Impact on profit: △1,192 million」
The product recall risk actually materialised in the form of the voluntary recall of 4.2 million diamond burs in China, a ¥1,481 million decline in sales and a ¥1,192 million impact on profit. The company explains that there were no issues with quality, efficacy or safety and no risk of harm to health. - FY2025-H1MaterialisedAnnual report
「The company decided to voluntarily recall its マニーダイヤバー product, whose generic name is dental diamond bur, after discovering deficiencies in part of the product registration information filed with the regulatory authorities of the People's Republic of China.」
The company states that, separately from product defect and recall risks, a voluntary recall in China actually occurred because of deficiencies in the product registration information. It states that there were no issues with quality, efficacy or safety and no risk of harm to patients' health. - FY2023RestatedAnnual report
「If a large volume of products were to be recalled due to unexpected defects or suspected defects, this could affect the Group's financial position and operating results through recall costs and other expenses, responses required under pharmaceutical and medical device regulations, and lower sales, as well as through a decline in confidence in the Group and impairment of corporate value.」
The company continues to identify the impact of product defects and large-scale recalls on costs, sales, regulatory responses, creditworthiness and corporate value as major risks. - FY2022-Q1MaterialisedAnnual report
「There was a minor adverse impact on revenue from アイレス針-related products and dental-related products as a result of the voluntary product recall. The company takes this recall seriously and is strengthening its management systems while working to prevent a recurrence and restore confidence.」
The company states that the previously disclosed potential risks of medical device defects and recalls actually materialised in the form of a voluntary product recall and a minor adverse impact on revenue from アイレス針 and dental-related products. - FY2017RestatedAnnual report
「If a large-scale product recall becomes necessary due to an unexpected defect or suspected defect, it could materially affect the group’s financial position and operating results through recall costs and other expenses, lower revenue and other effects.」
The company continues to disclose risks related to medical device defects, recalls, damages claims and litigation related to laws and regulations. - FY2016First statedAnnual report
「If a large-scale product recall becomes necessary due to an unexpected defect or suspected defect, it could materially affect the group’s financial position and operating results through recall costs and other expenses, lower revenue and other effects.」
Assuming a quality control and quality assurance framework is in place, the company identifies accidental defects, product recalls, damages claims and litigation related to laws and regulations as risks.