Reworded10-Q 2026-10-21 vs 10-K 2026-02-03
Risk factors in the latest filings
17 new paragraphs in the 10-K, 7 new in the latest 10-Q
New in the 10-K
Paragraphs with nothing like them in last year's 10-K
17 paragraphs in Risk Factors of the 10-K filed Feb 3, 2026 with nothing like them in the 10-K filed Jan 31, 2025. Quoted exactly. Paragraphs that were only edited are under 10-K change.
Compared with the Risk Factors in the latest 10-K of the other 59 Health care companies: a paragraph with at least half its words the same at another company is called similar, and the companies are listed under it. A paragraph most of them have is marked boilerplate. No line means no other company has one like it. This counts text; it does not say how serious a risk is.
The UK is in the process of overhauling its medical device regulatory framework following its departure from the European Union (“EU”). The UK regulatory framework will apply in Great Britain only, as Northern Ireland continues to follow the EU Medical Devices Regulation (“MDR”). New post-market surveillance requirements took effect on June 16, 2025, while a draft of additional rules governing device classification and pre-market approval pathways are expected to be published in 2026. The divergence of the new UK rules from EU law could adversely affect or delay our ability to obtain approval for our medical device products in the UK. In addition, any delays in implementation, changes in interpretation, or additional requirements under the new UK regime could adversely affect our ability to market and service our products in Great Britain, which could have adverse impacts on our business.
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More generally, several governments, including the U.S., have raised the possibility of policies to induce “re-shoring” of supply chains, less reliance on imported supplies, and greater national production. Examples include potential “Buy America” requirements in the U.S. If such steps by local governments triggered retaliation in other markets restricting access to foreign products in purchases by their government-owned healthcare systems, the result may have an adverse impact on our business, financial condition, or result of operations.
Similar paragraph at 1 of 59 other Health care companies: BAXRead in the 10-K ↗
The manufacture of our products requires the timely delivery of a sufficient amount of quality components and materials and is highly exacting and complex, due in part to complex trade and strict regulatory requirements. Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers or single-sourced suppliers due to, among other things, quality considerations, unique intellectual property considerations, or constraints associated with regulatory requirements. We generally purchase components through purchase orders rather than long-term supply agreements
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regulatory authorization or certification in such countries or within such regions and causes, by action or inaction, the suspension of such marketing authorization or certification or sanctions for non-compliance. It may be difficult, expensive, and time-consuming for us to re-establish access or regulatory compliance in such cases.
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We believe that a critical contributor to our success has been our corporate culture, which we believe fosters innovation, teamwork, and a focus on execution, as well as facilitates critical knowledge transfer and knowledge sharing.
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Show the other 11
In the U.S., legislation related to AI technologies has been introduced at the federal level and has been enacted by various states. At the federal level, in January 2025, the Trump administration rescinded an executive order relating to the safe and secure development of AI technologies that was previously implemented by the Biden administration. The Trump administration then issued a new executive order that, among other things, requires certain agencies to develop and submit to the president action plans to “sustain and enhance America’s global AI dominance,” and to specifically review and, if possible, rescind rulemaking taken pursuant to the rescinded Biden executive order. Additionally, in December 2025, the Trump administration’s “Ensuring a National Policy Framework for Artificial Intelligence” Executive Order was signed. This order calls for federal standards and legislation that would preempt conflicting state AI regulations and create a federal litigation task force focused on challenging state AI laws in court. The Trump administration may continue to rescind other existing federal orders and/or administrative policies relating to AI technologies or may implement new executive orders and/or other rule making relating to AI technologies in the future. U.S. states continue to advance a patchwork of AI regulatory frameworks, including general requirements around transparency, risk-management, and accountability for AI technologies. Several states—such as Colorado, California, and Connecticut—have enacted or proposed laws governing high-risk AI uses, including rules that address algorithmic discrimination, impact assessments, and consumer disclosures. A growing subset of these efforts specifically target health-related AI, with states like Illinois and New York adopting provisions that regulate AI used in clinical decision-support, diagnostics, and other health-related functions, often requiring heightened testing, documentation, or oversight. Such additional regulations, and uncertainty around their enforceability, may impact our ability to develop, use, and commercialize AI technologies in the future.
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Other jurisdictions where we operate have already or are also expected to introduce guidelines and regulations around the use of AI within the next few years. The cost to comply with such laws, regulations, decisions, and/or guidance interpreting existing laws, or to adjust our business plans based on changes to how such laws are enforced, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI technologies). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition, and results of operations.
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Further, in the U.S., when HIPAA does not apply, according to the Federal Trade Commission (the “FTC”), violating consumers’ privacy rights or failing to take appropriate steps to keep consumers’ personal information secure may constitute
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If a prolonged government shutdown occurs, or if funding shortages, staffing limitations, or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA, other regulatory authorities, or notified bodies to timely review and process our regulatory submissions, which may have an adverse effect on our business, financial condition or results of operations.
Similar paragraph at 1 of 59 other Health care companies: RMDRead in the 10-K ↗
In the EU, subject to the transitional provisions and in order to sell our products in EU member states, our products must comply with the general safety and performance requirements of the EU MDR, which repeals and replaces the MDD. Compliance with these requirements is a prerequisite to be able to affix the CE mark to our products, without which they cannot be sold or marketed in the EU.
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In addition, once our devices are certified under the EU MDR, we must inform the notified body that carried out the conformity assessment of the medical devices that we market or sell in the EU and the EEA of any planned substantial changes to our quality system or substantial changes to our medical devices that could affect compliance with the general safety and performance requirements laid down in Annex I to the EU MDR or cause a substantial change to the intended use for which the device has been CE marked. The notified body will then assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU MDR. If the assessment is favorable, the notified body will issue a new certificate of conformity or an addendum to the existing certificate attesting compliance with the general safety and performance requirements and quality system requirements laid down in the Annexes to the EU MDR. The notified body may disagree with our proposed changes and product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business.
If we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU. The aforementioned EU rules are generally applicable in the EEA. Non-compliance with the above requirements would also prevent us from selling our products in these three countries.
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able to obtain FDA and/or IRB approval to undertake clinical trials in the U.S. for any new devices that we intend to market in the U.S. in the future.
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Subject to the transitional provisions, in order to sell our products in EU member states, our products must comply with the general safety and performance requirements of the EU MDR. Compliance with these requirements is a prerequisite to be able
Read in the 10-K ↗
In addition, the EU regulatory landscape concerning medical devices recently evolved and continues to undergo legislative changes. On May 26, 2021, the EU MDR became applicable and repealed and replaced the EU MDD and the Active Implantable Medical Devices Directive. Unlike directives, which must be implemented into the national laws of the EU member states, regulations are directly applicable (i.e., without the need for adoption of EU member state laws implementing them) in all EU member states and are intended to eliminate current differences in the regulation of medical devices among EU member states. The EU MDR, among other things, is intended to establish a uniform, transparent, predictable, and sustainable regulatory framework across the EU for medical devices and ensure a high level of safety and health while supporting innovation. These requirements are in active implementation and may change as the European Commission adopts additional implementing acts and considers targeted revisions to related medical device rules. In addition, on December 16, 2025, the European Commission published a targeted revision proposal of the EU MDR to address structural issues, certification delays, and burdens on small and medium-sized enterprises (SMEs). The proposal will enter the ordinary legislative procedure and is not expected to be adopted before 2027.
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all payments, transfers of value, or ownership or investment interests not reported in an annual submission. Device manufacturers are required to submit reports to CMS by the 90th day of each calendar year.
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•changes in recommendations regarding our stock or more favorable relative recommendations about our competitors by industry or securities analysts;
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New in the latest 10-Q
Paragraphs in the 10-Q filed Oct 21, 2026 that were not in the one before
7 paragraphs in the 10-Q filed Oct 21, 2026 with nothing like them in the 10-Q filed Jul 21, 2026 (at least half the words must differ; new numbers alone do not count). Quoted exactly, grouped by the item heading above them. This is text that changed, not a judgement of how serious it is.
Financial statements and notes
expenses for the three and nine months ended September 30, 2026, and a corresponding liability in other accrued liabilities as of September 30, 2026.
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Following the Supreme Court’s ruling, the U.S. imposed a temporary 10% import surcharge under Section 122 of the Trade Act of 1974. The Section 122 surcharge applied to most imports entered for consumption, or withdrawn from warehouse for consumption, from February 24, 2026 through July 24, 2026, subject to certain exemptions, including qualifying goods from Canada and Mexico under the United States-Mexico-Canada Agreement (“USMCA”).
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Effective July 24, 2026, following the expiration of the temporary Section 122 surcharge, the U.S. imposed additional duties under Section 301 of the Trade Act of 1974 on products from 60 trading partners in connection with determinations by the Office of the U.S. Trade Representative concerning their prohibition and enforcement of bans on imports produced with forced labor. The additional duties are generally imposed at rates of 10% or 12.5%, depending on the originating economy and applicable treatment, and are subject to certain product exemptions. The scope, rates, exemptions, and duration of these and other tariff actions remain subject to further governmental action and could change.
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The Japanese Ministry of Health, Labor, and Welfare (“MHLW”) considers reimbursement for procedures in April of even-numbered years. The process for obtaining reimbursement requires Japanese university hospitals and surgical societies,
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• Operating income included a charge of $450 million in connection with the settlement of antitrust class action litigation.
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Beginning in the first half of 2027, we expect to implement a set of instrument pricing actions, including extending the number of uses for a subset of core EndoWrist instruments on our fourth- and fifth-generation da Vinci platforms and introducing volume-based pricing, both of which are intended to reduce the instrument cost per procedure for our customers. The introduction of these instruments with extended use is the result of investment in our product design and quality, and in our manufacturing processes, and is targeted at reducing cost in a set of benign procedures and lower-acuity cases where customers are more cost sensitive. In addition, beginning in the fourth quarter of 2026, we expect to implement pricing reductions in China in response to the NHSA unified national framework. Taken together, we expect these pricing actions to reduce da Vinci instruments and accessories revenue per procedure by approximately 3% to 5% once fully implemented, excluding the effect of changes in procedure, product, and geographic mix. The ultimate impact of these pricing actions will depend on various factors, including the pace of implementation and customer response, and could differ materially from our expectations.
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During the three and nine months ended September 30, 2026, a charge of $450 million was recognized in connection with the settlement of an antitrust class action litigation. Refer to Note 8 to the Condensed Consolidated Financial Statements (Unaudited) included in Part I, Item 1 for more information on the class action litigation settlement.
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10-Q against the 10-K
The 10-Q's risk factors against the 10-K
Item 1A of the 10-Q filed Oct 21, 2026 against Item 1A of the 10-K filed Feb 3, 2026.
A 10-Q repeats only the risks that changed, so a 10-K paragraph that is missing from it is not counted as removed.
Added is a paragraph with nothing like it in the 10-K, Reworded a sentence that is in both with several words changed,
Quiet changes a sentence in both where one to four words changed and one is a hedge or a modal
(cut words struck through, new words highlighted and underlined).
Text on the page, not a score; each links to the filing at sec.gov.
Reworded10-Q 2026-10-21 vs 10-K 2026-02-03
Reworded10-Q 2026-10-21 vs 10-K 2026-02-03
Reworded10-Q 2026-10-21 vs 10-K 2026-02-03
THIRD PARTIES MAY OFFER TO SELL REMANUFACTURED OR UNAUTHORIZED INSTRUMENTS AND ACCESSORIES TO OUR CUSTOMERS OR PROVIDE UNAUTHORIZED SERVICE ON OUR SYSTEMS, WHICH COULD ADVERSELY IMPACT SAFETY, OUR FINANCIAL RESULTS, CREATE SAFETY ISSUES, AND HARM OUR REPUTATION.
Reworded10-Q 2026-10-21 vs 10-K 2026-02-03
Third parties have offered, and may continue to offer, customers counterfeit instruments and accessories and/or instruments and accessories that have been remanufactured and/or are unauthorized, including instruments that have been remanufactured to support the use of some of our limited-use instruments beyond their labeled useful life.