FDA Recall of da Vinci S, Si Tenaculum Forceps 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 2095 units of the da Vinci S, Si Tenaculum Forceps Instrument due to complaints about frayed or broken pitch cables, affecting surgical procedures in the United States and international markets.
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, fda, Devices.
Recall Article
What Happened
Intuitive Surgical, Inc. initiated a voluntary recall of the da Vinci S, Si Tenaculum Forceps Instrument due to an increase in complaints regarding frayed or broken pitch cables on these reusable surgical instruments. This recall is classified as Class II by the FDA.
Which Products Are Affected
The affected products are the da Vinci S, Si Tenaculum Forceps Instrument with model/catalog number 420207. A total of 2095 instruments are involved. The products include GTIN: 00886874111659 and various lot codes and system numbers such as Material Number: 420207-06, 420207-07, 420207-09, and 420207-10, along with specific da Vinci System Numbers like SH1378, SH0935, and others as listed in the recall details. Distribution occurred nationwide in the United States, specifically in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA, as well as in countries including Argentina, Austria, Belgium, Brazil, Canada, and many others.
What You Should Do
Consumers and healthcare providers who have the affected instruments 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 returning or replacing the instruments to ensure safety.
Why This Matters
This recall highlights potential risks in surgical procedures due to instrument malfunctions, which could impact patient safety in medical settings. It affects a significant number of devices distributed across the U.S. and internationally, emphasizing the need for proper maintenance and monitoring of medical equipment.
Source
Attribution: FDA Recall Number Z-1700-2026, Event ID 98408. For more information, refer to the FDA website.
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 (1,815 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.