Recall of da Vinci S, Si Double Fenestrated Grasper 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 2370 units of the da Vinci S, Si Double Fenestrated Grasper 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 16, 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 Double Fenestrated Grasper Instrument because of increased complaints for broken or frayed grip cables in these reusable instruments.
Which Products Are Affected
The affected product is the da Vinci S, Si Double Fenestrated Grasper Instrument with model/catalog number 420189. The quantity affected is 2370 units. It includes GTIN: 00886874111581 and FDA Medical Device Listing Number: D088920. Distribution occurred 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 worldwide in countries including Argentina, Brazil, Canada, and others. The recall involves various lot codes and batch numbers, such as M10120911 SH1182, M10130103 SH1182, and many more as listed in the recall notice.
What You Should Do
Consumers who have the affected product should contact Intuitive Surgical, Inc. at their address, 1266 Kifer Rd, Sunnyvale, CA 94086-5304, as the recall was initiated via letter. Follow the firm's instructions for returns or further guidance.
Why This Matters
This recall involves surgical instruments that could malfunction during procedures, potentially affecting patient safety due to the risk of cable failures.
Source
FDA recall notice: https://www.fda.gov/ (Recall Number: Z-1697-2026)
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 (1,394 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.