FDA Medical devices recall ·
da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S… recall
- Recall number
- Z-1698-2026
- Date
- (initiated December 9, 2025)
- Company / brand
- Intuitive Surgical, Inc.
1266 Kifer Rd, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7819
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA
Why was it recalled?
Due to increased complaints for broken/frayed grip cables for reusable instruments.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: 420194, Mega Needle Driver GTIN: 00886874111611 FDA Medical Device Listing Number: D088920 Material Number: 420194-08 Batch / System Numbers: M10120201 SH1182 M20120412 SH1182 M10130121 SH1570 M10130306 SH1570 M10110602 SH0547 M10110627 SH0547 M10121129 SH0059 M10121214 SH0059 M10130429 SH0059 M10130521 SH0059 M10121105 SH1557 M10130517 SH1837 M10121109 SH1390 M10130508 SH1390 M10131004 SH1390 M10130306 USG689 M10130412 USG689 M10110302 SH1368 M10110614 SH1368 M10110620 SH1368 M10110817 SH1368 M10120705 SH1368 M10121022 SH1368 M10130429 SH1368 M10130509 SH1368 M10130722 SH1368 M10110131 USG294 M10110511 USG294 M10110616 USG294 M10110811 USG294 M10111003 USG294 M20111103 USG294 M10111206 USG294 M20120103 USG294 M10120130 USG294 M10120305 USG294 M10120425 USG294 M10120713 USG294 M10121004 USG294 M10121017 USG294 M10121022 USG294 M10121105 USG294 M10121107 USG294 M10121206 USG294 M10121207 USG294 M10130108 USG294 M10130112 USG294 M10130201 USG294 M10130213 USG294 M10130215 USG294 M10130529 USG294 M11130608 USG294 M10130718 USG294 M10130829 USG294 M10120321 SG2026 M10120605 SG2026 M10111114 SH0825 M10110330 SH0935 M10110401 SH0935 M10120123 SH0935 M10120313 SH0935 M10120404 SH0935 M10120802 SH0935 M10120919 SH0935 M10121121 SH0935 M10110302 SH0729 M10110503 SH0729 M10110701 SH0729 M10110809 SH0729 M10110817 SH0729 M10110825 SH0729 M10110913 SH0729 M10110923 SH0729 M10111116 SH0729 M20111123 SH0729 M10111201 SH0729 M10120120 SH0729 M10120130 SH0729 M10120210 SH0729 M1012
Distribution
Worldwide - U.S. Nationwide distribution 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. The countries of Argentina, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Ecuador, France, Germany, Greece, Guadeloupe, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
States: California Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Missouri Mississippi North Carolina New Jersey New York Ohio Pennsylvania Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1698-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.