Recall of da Vinci S, Si Mega Needle Driver Instrument Due to Cable Issues
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Intuitive Surgical, Inc. is recalling 7819 units of the da Vinci S, Si Mega Needle Driver Instrument because of increased complaints about broken or frayed grip cables, affecting distribution in the United States and worldwide.
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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Recall Article
What Happened
Intuitive Surgical, Inc. initiated a voluntary recall due to increased complaints for broken or frayed grip cables in the reusable instruments.
Which Products Are Affected
The affected product is the da Vinci S, Si Mega Needle Driver Instrument, with model number 420194. A total of 7819 units are involved, distributed nationwide in the United States in states including 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 to countries such as Argentina, Brazil, Canada, and others. Specific lot codes and batch numbers include those listed in the FDA notice, such as Lot Code: 420194 and various batch/system numbers like M10120201 SH1182.
What You Should Do
Consumers should follow the initial firm notification, which was sent via letter, and contact Intuitive Surgical, Inc. at their address, 1266 Kifer Rd, Sunnyvale, CA 94086-5304, for instructions on returns or refunds.
Why This Matters
This recall affects 7819 medical devices used in surgical procedures, potentially impacting patient safety due to the risk of cable failures.
Source
FDA Recall Number: Z-1698-2026. For more information, refer to the FDA website.
Original source: FDA Official Notice ↗
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