Da Vinci ASSY PSS SP1098 Recall
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 454 units of Da Vinci ASSY, PSS, SP1098 surgical system components due to potential E-brake issues that may cause uncontrolled motion or patient injury.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references Worldwide. 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.
What Happened
Intuitive Surgical, Inc. initiated a voluntary recall because operative components of surgical systems were potentially distributed with an E-brake retainer pin. In the event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. If the pin moves or backs out, it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury, crushing injury, or bleeding.
Which Products Are Affected
The recall affects Da Vinci ASSY, PSS, SP1098, Part Number: 380601. A total of 454 units are affected. The UDI is 00886874114605. Affected serial numbers are listed in the recall notice. Distribution was worldwide, including US nationwide distribution in CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.
What You Should Do
Consumers should follow instructions provided by Intuitive Surgical, Inc. regarding the recalled devices. The recalling firm is located at 1266 Kifer Rd, Sunnyvale, CA 94086-5304.
Why This Matters
The recall involves surgical system components where a defect could lead to uncontrolled motion resulting in patient tissue injury, crushing injury, or bleeding.
Source
FDA recall number Z-2521-2026, event ID 98701. Classification: Class II. Report date 20260701.
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 (1,691 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.