What dominates the section
- Medical-device regulation, product quality, lawsuits, and manufacturing or sterilization failures dominate the risk section.
- Supply-chain dependence on sole-source components and global disruptions threatens production and margins.
- Growth depends on innovation, reimbursement, competition, cybersecurity, and successful acquisitions.
The risks most specific to Becton Dickinson &
- Legal, Quality and Regulatory Risks
We are subject to extensive regulation
Global healthcare, environmental, privacy, product-safety, anti-corruption, and other regulations could increase costs or restrict BD’s operations and products.
- Legal, Quality and Regulatory Risks
Defects or quality issues associated with our products could adversely affect the results of our operations
Design defects, component failures, improper use, or inadequate warnings could injure patients and trigger recalls, liability, or lost sales.
- Legal, Quality and Regulatory Risks
We are subject to lawsuits
Lawsuits and investigations include claims involving ethylene oxide, hernia implants, pelvic products, antitrust, securities, and other product-liability matters.
- Operational Risks
A reduction or interruption in the supply of certain raw materials and components could adversely affect our operating results
Some raw materials and components come from sole suppliers, so interruptions or quality problems could halt products or increase costs.
- Operational Risks
Interruption of our manufacturing or sterilization operations could adversely affect our business
Manufacturing or sterilization sites could be disrupted by outages, cyber incidents, disasters, labor issues, equipment failures, or regulation.
- Business, Economic and Industry Risks
Our future growth is dependent in part upon the development of new products, and there can be no assurance that such products will be developed
BD’s growth strategy requires successful development, clinical testing, regulatory approval, and commercialization of new medical products.
- Business, Economic and Industry Risks
Market dynamics, changes in reimbursement practices and coverage policies and third-party payer cost containment measures could affect the demand for our products and the prices at which they are sold
Reimbursement changes, coverage decisions, and payer cost controls could reduce demand or the prices healthcare providers pay for BD products.
- Operational Risks
Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations
Cyberattacks or failures affecting BD’s systems or third-party providers could disrupt operations or expose confidential customer and personal information.
- General Business Risks
We cannot guarantee that any of our strategic acquisitions, investments or alliances will be successful
Acquisitions, investments, and alliances may fail to deliver expected benefits or require costly, management-intensive integration.
All 30 risk factors
Headings as the filing states them, in filing order.
Business, Economic and Industry Risks
- 01Global economic conditions, including inflation and supply chain disruptions, could continue to adversely affect our operations
- 02assets and liabilities, as well as our cash flows
- 03Our international operations subject us to certain business risks
- 04The medical technology industry is very competitive
- 05resources than we do. We face competition across all our product lines and in each market in which our products are sold on the basis of product features, clinical or economic outcomes, product quality, availability, price, services and other factors
- 06We are subject to foreign currency exchange risk
- 07Market dynamics, changes in reimbursement practices and coverage policies and third-party payer cost containment measures could affect the demand for our products and the prices at which they are sold
- 08Our future growth is dependent in part upon the development of new products, and there can be no assurance that such products will be developed
- 09We are subject to risks associated with public health crises, such as pandemics and epidemics, which could have a material adverse effect on our business. The nature and extent of impacts from any such events are highly uncertain and unpredictable
- 10In addition, public health crises could result in significant volatility in our global supply chain network, including shortages in supply or disruptions or delays in shipments, as well as price increases, of certain materials or components used in our products and increases in transportation costs
- 11Reductions in customers’ research budgets or government funding may adversely affect our business
- 12We need to attract and retain key employees to be competitive
Operational Risks
- 13Cybersecurity incidents and breaches or breakdowns of our information and technology systems or infrastructure could have a material adverse effect on our operations
- 14Cost volatility could adversely affect our operations
- 15A reduction or interruption in the supply of certain raw materials and components could adversely affect our operating results
- 16alternative routes, transportation modes, and replenishment timings to preempt and mitigate associated risks, but no assurance can be given that these efforts will adequately address these challenges and disruptions
- 17Interruption of our manufacturing or sterilization operations could adversely affect our business
- 18Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business, financial condition or results of operations
Legal, Quality and Regulatory Risks
- 19We are subject to lawsuits
- 20civil investigative demands could ultimately have a material adverse effect on our results of operations, financial condition and liquidity, and could distract management from the operations of the business
- 21We are subject to extensive regulation
- 22Defects or quality issues associated with our products could adversely affect the results of our operations
- 23Our operations are dependent in part on patents and other intellectual property assets
Risks Relating to Our Indebtedness
- 24We may not be able to service all of our indebtedness
- 25The agreements that govern our indebtedness impose restrictions that may affect our ability to operate our businesses
General Business Risks
- 26We cannot guarantee that any of our strategic acquisitions, investments or alliances will be successful
- 27Natural disasters, war and other events beyond our control could disrupt our business and adversely affect our future revenues and operating income
- 28Information About our Executive Officers
- 29Richard Byrd 57 Executive Vice President and President, Interventional Segment since September 2022; Worldwide President, BD Medication Delivery Solutions from March 2019 to September 2022; Worldwide President, Preanalytical Systems from December 2016 to February 2019
- 30Shana Neal 59 Executive Vice President and Chief People Officer since April 2022; Chief Human Resources Officer of Owens & Minor from April 2018 to March 2022
Other Becton Dickinson & 10-Ks
- 2025 10-K risk factors
28 risks. Integration risks from the pending Waters transaction dominate the new risk disclosures alongside traditional medical device regulatory hurdles. Product liability exposure from ethylene oxide and hernia repair products poses ongoing litigation threats.
Filed Nov 25, 2025
About this page
Item 1A of the 10-K on EDGAR was split into its risk factors and, where the company's previous 10-K is on file, each heading was matched to last year's and the text compared word for word. The headings are the filing's own. The one-line readings and the overview were written by a language model from the text of the new, dropped, and rewritten risks; they refer to risks by position and cannot misquote a heading.