FDA Warns Intuitive Surgical Recalls 8mm SureForm 30 Gray Reloads
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 05 2026
0mins
The FDA is aware that Intuitive Surgical has issued a letter to affected customers recommending all 8mm SureForm 30 gray reloads for curved-tip staplers be removed from where they are used or sold. On March 11, 2026, Intuitive Surgical sent all affected customers a letter, the FDA said, noting that the agency "has identified this recall as the most serious type."
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Analyst Views on ISRG
Wall Street analysts forecast ISRG stock price to rise
20 Analyst Rating
16 Buy
4 Hold
0 Sell
Strong Buy
Current: 438.100
Low
575.00
Averages
637.32
High
740.00
Current: 438.100
Low
575.00
Averages
637.32
High
740.00
About ISRG
Intuitive Surgical, Inc. develops, manufactures, and markets da Vinci surgical systems and the Ion endoluminal system. The Company specializes in invasive care and robotic-assisted surgery. Its technologies include the da Vinci surgical systems and the Ion endoluminal system. The da Vinci surgical system is designed to enable surgeons to perform a range of surgical procedures within its targeted general surgery, urologic, gynecologic, cardiothoracic, and head and neck specialties and consists of a surgeon's console or consoles, a patient-side cart, and a high-performance vision system. The Ion endoluminal system is a flexible, robotic-assisted, catheter-based platform for which the cleared indication is minimally invasive biopsies in the lung and consists of a system cart, a controller, a catheter, and a vision probe. Its Ion system extends its commercial offering beyond surgery into diagnostic and endoluminal procedures.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Intuitive Surgical and Microsoft: Long-Term Investment Opportunities
- Financial Challenges for ISRG: Despite facing steep tariffs, Intuitive Surgical reported significant revenue and procedure volume growth in Q1, solidifying its market leadership in robotic-assisted surgery and indicating strong long-term growth potential.
- New Product Momentum: The latest da Vinci model accounted for 54% of the company's system placements in Q1, and its strong market adoption not only enhances technological advantages but also provides valuable feedback for future product improvements.
- Microsoft's AI Revenue Surge: Microsoft plans to invest $190 billion in AI-related capital expenditures by 2026, with its AI business already achieving an annual revenue run rate of $37 billion, reflecting a 123% year-over-year growth and showcasing the company's robust performance in the AI revolution.
- Cloud Computing Leadership: Microsoft's cloud backlog surged 99% year-over-year to $627 billion in the latest quarter, and combined with its AAA credit rating and a 153% dividend increase over the past decade, this further solidifies its appeal as a long-term investment.
See More
Market Outlook for Intuitive Surgical and Microsoft
- Solid Financial Performance: Despite facing steep tariffs, Intuitive Surgical achieved significant revenue and procedure volume growth in Q1, further solidifying its market leadership in robotic-assisted surgery, demonstrating the company's strong competitive position in the medical device sector.
- Sustained Technological Edge: The latest da Vinci 5 model accounted for nearly 54% of the company's installed systems in Q1, and this strong market acceptance not only enhances the company's technological advantage but also provides valuable feedback for future product improvements.
- AI-Driven Growth Potential: Microsoft plans to invest $190 billion by 2026 to support its AI-related strategies; despite concerns about its services being replaced by AI, the company has already achieved an annual revenue run rate of $37 billion in its AI business, reflecting a 123% year-over-year growth and showcasing its adaptability in technological transformation.
- Cloud Market Leadership: Microsoft's cloud backlog surged 99% year-over-year to $627 billion in the most recent quarter, and combined with its AAA credit rating and a 153% dividend increase over the past decade, this further underscores its attractiveness as a long-term investment.
See More
Intuitive Surgical's Single-Port Platform Growth Potential
- Market Expansion Potential: Intuitive Surgical's single-port (SP) platform saw a 68% year-over-year increase in procedures in Q1 2026, significantly outpacing overall da Vinci procedure growth, indicating accelerated surgeon adoption and potential new market opportunities for the company.
- New Indications Driving Growth: The recent clearance for new procedures, including nipple-sparing mastectomy, broadens the clinical applicability of the SP platform, which is expected to enhance surgeon willingness to adopt robotic-assisted approaches, thereby driving market share growth.
- Ecosystem Investment: Intuitive Surgical is aggressively investing in the development of the SP ecosystem, launching the SP stapler to enhance surgical complexity while improving workflow through instrumentation enhancements and surgeon training, further strengthening its competitive position in the market.
- Strategic Positioning Debate: Management increasingly frames the SP platform not merely as a substitute for multi-port da Vinci procedures but as a tool for market expansion, particularly in historically open surgery or conventional laparoscopy, potentially attracting more surgeons to robotic technology.
See More
Intuitive Unveils da Vinci 5 Innovations and Security Enhancements
- da Vinci 5 Innovations: Intuitive is set to release over 100 updates that enhance collaboration and connectivity for da Vinci 5 users, significantly improving outcomes across the surgical ecosystem and transforming the learning experience for over 101,000 da Vinci-trained surgeons worldwide.
- Enhanced Safety and Reliability: By implementing software and hardware updates, Intuitive guarantees a 99% actual uptime for the da Vinci 5 system, further bolstering trust among hospitals and patients, which supports broader applications of minimally invasive surgery.
- Force Feedback Instrument Improvements: The usage count for six Force Feedback instruments has increased from six to fifteen, meeting customer demand and reducing per-procedure costs, which is expected to drive improved surgical outcomes and further technological advancements.
- Multi-Function Tools and Digital Measurement: New features will allow surgeons to initiate tool removal directly from the console and enable digital measurements of 3 to 15 centimeters during surgery, enhancing precision and efficiency, thereby promoting the wider adoption of minimally invasive surgery.
See More
Symbotic's Warehouse Automation Business Shows Significant Growth
- Contracted Revenue Growth: Symbotic boasts a contracted backlog of $22.70 billion, ensuring multi-year revenue visibility, with Q2 FY2026 revenue rising 23.1% year-over-year to $676.48 million, reflecting strong demand in North America's large distribution centers.
- Profitability Improvement: Adjusted EBITDA more than doubled year-over-year to $77.75 million, with gross margin expanding from 20.2% to 22.2%, indicating a significant shift in profitability, while management projects Q3 revenue between $700 million and $720 million.
- Customer Base Expansion: The GreenBox joint venture with SoftBank offers warehouse-as-a-service against a $500 billion outsourced warehousing market, anchored by a contract worth approximately $11 billion, broadening Symbotic's market opportunities.
- Optimistic Market Outlook: Despite a 20.92% decline in Symbotic's stock price year-to-date, the operational progress and growth in customer contracts suggest substantial future potential in the automation sector, making it a noteworthy consideration for investors.
See More
Medtronic: Investment Opportunities Amid Adversity
- Stable Dividend Growth: Medtronic has increased its dividend for 48 consecutive years, demonstrating its ability to navigate adversity, and is just two years away from achieving Dividend King status, attracting interest from value and dividend investors.
- Attractive Stock Price: Despite a 40% decline from its 2021 peak, Medtronic's P/E ratio stands at 21, below its five-year average, while the dividend yield has reached a historical high of 3.7%, providing a compelling buying opportunity for investors.
- Surge in Surgical Robot Sales: Medtronic is ramping up sales of its Hugo surgical robot, which is expected to drive company growth amid strong demand in the surgical robotics market, where competitor Intuitive Surgical commands a P/E ratio of 52, highlighting the market's valuation of this sector.
- Business Restructuring Near Completion: After several years of streamlining its operations, Medtronic's transformation process is largely complete, with a growth rebound on the horizon, particularly driven by the Hugo surgical robot, making it an attractive option for long-term investors.
See More
Intuitive Surgical and Microsoft: Long-Term Investment Opportunities
- Financial Challenges for ISRG: Despite facing steep tariffs, Intuitive Surgical reported significant revenue and procedure volume growth in Q1, solidifying its market leadership in robotic-assisted surgery and indicating strong long-term growth potential.
- New Product Momentum: The latest da Vinci model accounted for 54% of the company's system placements in Q1, and its strong market adoption not only enhances technological advantages but also provides valuable feedback for future product improvements.
- Microsoft's AI Revenue Surge: Microsoft plans to invest $190 billion in AI-related capital expenditures by 2026, with its AI business already achieving an annual revenue run rate of $37 billion, reflecting a 123% year-over-year growth and showcasing the company's robust performance in the AI revolution.
- Cloud Computing Leadership: Microsoft's cloud backlog surged 99% year-over-year to $627 billion in the latest quarter, and combined with its AAA credit rating and a 153% dividend increase over the past decade, this further solidifies its appeal as a long-term investment.
See More
Market Outlook for Intuitive Surgical and Microsoft
- Solid Financial Performance: Despite facing steep tariffs, Intuitive Surgical achieved significant revenue and procedure volume growth in Q1, further solidifying its market leadership in robotic-assisted surgery, demonstrating the company's strong competitive position in the medical device sector.
- Sustained Technological Edge: The latest da Vinci 5 model accounted for nearly 54% of the company's installed systems in Q1, and this strong market acceptance not only enhances the company's technological advantage but also provides valuable feedback for future product improvements.
- AI-Driven Growth Potential: Microsoft plans to invest $190 billion by 2026 to support its AI-related strategies; despite concerns about its services being replaced by AI, the company has already achieved an annual revenue run rate of $37 billion in its AI business, reflecting a 123% year-over-year growth and showcasing its adaptability in technological transformation.
- Cloud Market Leadership: Microsoft's cloud backlog surged 99% year-over-year to $627 billion in the most recent quarter, and combined with its AAA credit rating and a 153% dividend increase over the past decade, this further underscores its attractiveness as a long-term investment.
See More
Intuitive Surgical's Single-Port Platform Growth Potential
- Market Expansion Potential: Intuitive Surgical's single-port (SP) platform saw a 68% year-over-year increase in procedures in Q1 2026, significantly outpacing overall da Vinci procedure growth, indicating accelerated surgeon adoption and potential new market opportunities for the company.
- New Indications Driving Growth: The recent clearance for new procedures, including nipple-sparing mastectomy, broadens the clinical applicability of the SP platform, which is expected to enhance surgeon willingness to adopt robotic-assisted approaches, thereby driving market share growth.
- Ecosystem Investment: Intuitive Surgical is aggressively investing in the development of the SP ecosystem, launching the SP stapler to enhance surgical complexity while improving workflow through instrumentation enhancements and surgeon training, further strengthening its competitive position in the market.
- Strategic Positioning Debate: Management increasingly frames the SP platform not merely as a substitute for multi-port da Vinci procedures but as a tool for market expansion, particularly in historically open surgery or conventional laparoscopy, potentially attracting more surgeons to robotic technology.
See More
Intuitive Unveils da Vinci 5 Innovations and Security Enhancements
- da Vinci 5 Innovations: Intuitive is set to release over 100 updates that enhance collaboration and connectivity for da Vinci 5 users, significantly improving outcomes across the surgical ecosystem and transforming the learning experience for over 101,000 da Vinci-trained surgeons worldwide.
- Enhanced Safety and Reliability: By implementing software and hardware updates, Intuitive guarantees a 99% actual uptime for the da Vinci 5 system, further bolstering trust among hospitals and patients, which supports broader applications of minimally invasive surgery.
- Force Feedback Instrument Improvements: The usage count for six Force Feedback instruments has increased from six to fifteen, meeting customer demand and reducing per-procedure costs, which is expected to drive improved surgical outcomes and further technological advancements.
- Multi-Function Tools and Digital Measurement: New features will allow surgeons to initiate tool removal directly from the console and enable digital measurements of 3 to 15 centimeters during surgery, enhancing precision and efficiency, thereby promoting the wider adoption of minimally invasive surgery.
See More
Symbotic's Warehouse Automation Business Shows Significant Growth
- Contracted Revenue Growth: Symbotic boasts a contracted backlog of $22.70 billion, ensuring multi-year revenue visibility, with Q2 FY2026 revenue rising 23.1% year-over-year to $676.48 million, reflecting strong demand in North America's large distribution centers.
- Profitability Improvement: Adjusted EBITDA more than doubled year-over-year to $77.75 million, with gross margin expanding from 20.2% to 22.2%, indicating a significant shift in profitability, while management projects Q3 revenue between $700 million and $720 million.
- Customer Base Expansion: The GreenBox joint venture with SoftBank offers warehouse-as-a-service against a $500 billion outsourced warehousing market, anchored by a contract worth approximately $11 billion, broadening Symbotic's market opportunities.
- Optimistic Market Outlook: Despite a 20.92% decline in Symbotic's stock price year-to-date, the operational progress and growth in customer contracts suggest substantial future potential in the automation sector, making it a noteworthy consideration for investors.
See More
Medtronic: Investment Opportunities Amid Adversity
- Stable Dividend Growth: Medtronic has increased its dividend for 48 consecutive years, demonstrating its ability to navigate adversity, and is just two years away from achieving Dividend King status, attracting interest from value and dividend investors.
- Attractive Stock Price: Despite a 40% decline from its 2021 peak, Medtronic's P/E ratio stands at 21, below its five-year average, while the dividend yield has reached a historical high of 3.7%, providing a compelling buying opportunity for investors.
- Surge in Surgical Robot Sales: Medtronic is ramping up sales of its Hugo surgical robot, which is expected to drive company growth amid strong demand in the surgical robotics market, where competitor Intuitive Surgical commands a P/E ratio of 52, highlighting the market's valuation of this sector.
- Business Restructuring Near Completion: After several years of streamlining its operations, Medtronic's transformation process is largely complete, with a growth rebound on the horizon, particularly driven by the Hugo surgical robot, making it an attractive option for long-term investors.
See More
