BECTON DICKINSON & CO (BDX) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that BECTON DICKINSON & CO surfaced in its latest filing.

• U.S. Department of Commerce initiated a Section 232 investigation into imports of personal protective equipment, medical consumables, and medical equipment to determine threats to U.S. national security.
• Final NESHAP: Ethylene Oxide Emissions Standards for Sterilization Facilities regulation effective April 5, 2024, with initial compliance deadline April 2026 extended to April 2028 for medical device sterilization facilities by July 2025 executive order.April 5, 2024
• EPA published ID on January 14, 2025, regulating ethylene oxide as a sterilant with new occupational exposure limit, engineering controls, PPE, continuous monitoring, and maximum concentration limit.January 14, 2025
• CareFusion 303, Inc. subsidiary is operating under an amended Consent Decree that affects the BD Alaris™ infusion pump business in the United States.
• Operating under two warning letters issued by the FDA for Dispensing and Specimen Management businesses.
• On July 21, 2023, BD received 510(k) clearance from the FDA for its updated BD Alaris™ Infusion System.July 21, 2023
• EU Medical Device Regulation (Regulation (EU) 2017/745, 'EU MDR') imposes stricter requirements for marketing and sale of medical devices, with extended transition timelines until 2027 for certain higher-risk devices and 2028 for others.
• EU In Vitro Diagnostic Regulation (Regulation (EU) 2017/746, 'EU IVDR') applicable since May 2022 with transition periods for certain in vitro diagnostic medical devices.May 2022
• The Organization for Economic Cooperation and Development published Pillar Two Model Rules, imposing a 15% global minimum tax, effective in some jurisdictions in fiscal year 2025.2025
• Loss of 'well-known seasoned issuer' status upon filing of this annual report due to our entry into a December 2024 SEC Order.December 2024
• On July 13, 2025, we entered into a definitive agreement with Waters to combine our Biosciences and Diagnostic Solutions business with Waters; if consummated, our shareholders would own approximately 39.2% of the combined company and Waters shareholders approximately 60.8%, expected to close around the end of the first quarter of calendar year 2026, subject to conditions.July 13, 2025
• On April 1, 2022, we completed the spin-off of Embecta Corp. (NASDAQ: EMBC), which holds our former Diabetes Care business; the spin-off is intended to be a tax-free transaction for U.S. federal income tax purposes.April 1, 2022
• The company is a defendant in purported class action lawsuits for alleged antitrust violations and violations of federal securities laws.
• The company faces environmental and product liability claims relating to ethylene oxide.
• The company faces product liability claims relating to hernia repair implant products.
• The company faces product liability claims relating to surgical continence and pelvic organ prolapse products for women.
• The company faces product liability claims relating to vena cava filter products.
• The company faces product liability claims relating to implantable ports.
• The company is subject to government investigations and civil investigative demands regarding alleged violations of law in connection with federal and/or state healthcare programs such as Medicare or Medicaid.
• The company is subject to government investigations and civil investigative demands regarding alleged violations of federal securities laws.
• The company is subject to government investigations and civil investigative demands regarding alleged violations of federal contracting requirements.
• The company is subject to government investigations and civil investigative demands regarding alleged violations of sales and marketing practices.
• CMS has proposed expansion of its Competitive Bidding Program that could influence cost structure of devices reimbursed under Durable Medical Equipment, Prosthetic, Orthotic and Supplies payment system.