Recall of da Vinci S, Si Grasping Retractor Instrument
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 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,341 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.