Recall of da Vinci S and Si Monopolar Curved Scissors Instrument

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Intuitive Surgical, Inc. is recalling 86,904 units of the da Vinci S and Si Monopolar Curved Scissors 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.

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What Happened

Intuitive Surgical, Inc. is voluntarily recalling the da Vinci S and Si Monopolar Curved Scissors 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 and Si Monopolar Curved Scissors Instrument with model/catalog number 420179. A total of 86,904 units are involved. The distribution includes U.S. nationwide 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 worldwide in countries such as Argentina, Brazil, Canada, and others. Specific lot codes and batch numbers include various entries like M10101102, SH0935, and more as listed in the FDA notice.

What You Should Do

Consumers should follow the firm's initial notification via letter for instructions on the recall. Contact Intuitive Surgical, Inc. at their address: 1266 Kifer Rd, Sunnyvale, CA 94086-5304, for details on returns or refunds related to the affected instruments.

Why This Matters

This recall involves medical devices that could pose a risk due to potential malfunctions, affecting patient safety in surgical procedures. It highlights the importance of device reliability in healthcare, with 86,904 units impacted globally.

Source

FDA recall notice Z-1696-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Intuitive Surgical, Inc. is recalling 86,904 units of the da Vinci S and Si Monopolar Curved Scissors Instrument due to complaints of broken or frayed grip cables.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.