Recall of da Vinci S, Si Permanent Cautery Hook Instrument
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Intuitive Surgical, Inc. is recalling 6152 units of the da Vinci S, Si Permanent Cautery Hook Instrument due to complaints of frayed or broken pitch cables.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Intuitive Surgical, Inc. is recalling certain da Vinci S, Si Permanent Cautery Hook Instruments because of increased complaints regarding frayed or broken pitch cables on these reusable surgical instruments.
Which Products Are Affected
The affected products are the da Vinci S, Si Permanent Cautery Hook Instrument with model/catalog number 420183. The quantity affected is 6152 instruments. Distribution occurred nationwide in the United States, specifically in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA, as well as in countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam. Additional codes include Lot Code: 420183, GTIN: 00886874111536, FDA Medical Device Listing Number: D088920, and various Material Numbers such as 420183-05, 420183-06, 420183-10, 420183-11, 420183-12, 420183-14, 420183-15, and 420183-16, along with associated da Vinci System Numbers.
What You Should Do
Consumers should follow the initial firm notification, which was a letter, and contact Intuitive Surgical, Inc. for instructions on the voluntary recall regarding returns or refunds.
Why This Matters
This recall involves surgical instruments that could malfunction during use, potentially affecting patient safety in medical procedures. It highlights the importance of maintaining reliable medical devices to prevent any adverse health consequences.
Source
This information is from the FDA recall with number Z-1701-2026. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
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