Recall of da Vinci S, Si Grasping Retractor Instrument
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Intuitive Surgical, Inc. is recalling 2660 units of the da Vinci S, Si Grasping Retractor Instrument due to complaints of broken or frayed grip cables.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 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.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Intuitive Surgical, Inc. is recalling the da Vinci S, Si Grasping Retractor Instrument due to increased complaints for broken or frayed grip cables in reusable instruments.
Which Products Are Affected
The affected products are the da Vinci S, Si Grasping Retractor Instrument with model number 420278. A total of 2660 units are involved, distributed nationwide in the United States, specifically in the states of CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, and WI, as well as internationally in countries including Argentina, Brazil, Canada, and others. The recall includes various lot codes such as M10110613 SH1182, N10140725 SH1182, and more as listed in the FDA notice, with GTIN 00886874111772 and FDA Medical Device Listing Number D088920.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Intuitive Surgical, Inc. at their address, 1266 Kifer Rd, Sunnyvale, CA 94086-5304, for instructions on returns or refunds related to this recall.
Why This Matters
This recall involves medical devices used in surgical procedures, potentially affecting patient safety due to the risk of instrument failure.
Source
FDA Recall Number: Z-1699-2026, attributed to the FDA at their official website for medical device recalls.
Original source: FDA Official Notice ↗
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