CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

da Vinci S, Si Tenaculum Forceps Instrument recalled

Intuitive Surgical is recalling da Vinci S, Si Tenaculum Forceps Instrument, distributed nationwide in the US. The recall was initiated on 9 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 420207: Tenaculum Forceps Instrument GTIN: 00886874111659 FDA Medical Device Number: D088920 Material Number: 420207-06 da Vinci System Numbers: SH1378 SH0935 SH0935 SH0935 USG294 SH0761 SH0729 SH1182 SH1378 USG022 SH1378 SH1368 SH0059 SH1015 SH1182 SH0825 USG294 SH1390 USG022 SH0495 SH0495 SH1076 SH1390 SH1390 SH1390 SH1276 SH1385 USG022 SH0547 SH1385 SH1391 SH2144 SH0059 SH1279 SH0059 SH1390 SH1570 SH0059 SH1391 SG704 SH1570 SH0729 SH1385 SH1378 USG518 SH1385 SH1837 USG294 SH1368 SH1390 SH1385 SH1368 SG2026 SH1557 SH2144 SH1385 USG518 SH1279 USG294 SH1391 Material Number: 420207-07 da Vinci System Numbers: SH1391 SH1385 SH1385 SH1279 SH2125 SH0729 SH1368 USG721 SH1385 SH1997 SH2125 USG294 SH1378 SH1997 SH0035 SG704 SH1385 SH1279 SH1279 SH2125 SH1378 SH1378 SH0495 SH1390 SH1390 SH1385 SH2125 SH1378 SH1385 SH1279 USG721 SH1279 SH1837 USG518 SH1385 SH1378 USG022 SH1378 SH1570 SH1385 SH1385 SH0935 SH0935 SG704 SG704 SH1378 USG022 SH1385 SH1279 USG721 SH1279 USG518 SH1837 SH1279 USG022 SH1385 SH1385 SH1964 SH1385 SH1390 SH1279 SH1964 SH1385 SH1570 USG294 SH1182 SH1279 SH1279 USG022 SH1385 SH0825 USG294 SH0035 SH1276 SH2125 SH1279 RSH0152 USG518 SH1557 SH1837 SH1385 SH1390 SH1279 SH1390 SH1390 USG294 SH1385 SH1279 SH1385 SH1279 SH2125 USG721 SH1837 SH0035 SH1964 SH1837 SH1385 SH1385 SH1279 SH1279 RSH0152 SH1378 SH0495 Material Number: 420207-09 da Vinci System Numbers: RSH0152 SH1378 SH1385 SH1279 USG721 SH1279 SH1378 SH1385 USG721 SH1279 SH1182 SH1390 SH1076 USG721 SH1279 SH1182 SH1385 SH1837 SH1279 SH1837 SH1279 Material Number: 420207-10 da Vinci System Numbers: SH1279 SH1385 SH1390 SH1279 SH1385 SH1182 SH1368 SH1997 SH1279 USG721 SH1822 SH1557 SH1822 SH1964 SH1279 SH0495 SH1390 SH1279 SH1964 USG022 SH1822 SH1378 SH1182 SH1837 SH1279 SH1279 SH1279 SH1279 SH1997 SH1964 SH1964 SH1997 SH0761 SH1279 SH1837 SH1279 SH1279 SH1279 SH1390 SH1279 SH1997

Quantity recalled2095 instruments

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1700-2026
FDA event ID: 98408
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Dec 2025
FDA classified: 30 Mar 2026
Reported: 8 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

9 Dec 2025	Recall initiated by company
30 Mar 2026	Classified by FDA	+111 days
8 Apr 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A 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: N/A

Where it was distributed

U.S. Nationwide distribution 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. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.

Nationwide Arkansas California Connecticut Florida Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York Ohio

Questions about this recall

Why was it recalled?

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Which lots are affected?

Lot Code: 420207: Tenaculum Forceps Instrument GTIN: 00886874111659 FDA Medical Device Number: D088920 Material Number: 420207-06 da Vinci System Numbers: SH1378 SH0935 SH0935 SH0935 USG294 SH0761 SH0729 SH1182 SH1378 USG022 SH1378 SH1368 SH0059 SH1015 SH1182 SH0825 USG294 SH1390 USG022 SH0495 SH0495 SH1076 SH1390 SH1390 SH1390 SH1276 SH1385 USG022 SH0547 SH1385 SH1391 SH2144 SH0059 SH1279 SH0059 SH1390 SH1570 SH0059 SH1391 SG704 SH1570 SH0729 SH1385 SH1378 USG518 SH1385 SH1837 USG294 SH1368 SH1390 SH1385 SH1368 SG2026 SH1557 SH2144 SH1385 USG518 SH1279 USG294 SH1391 Material Number: 420207-07 da Vinci System Numbers: SH1391 SH1385 SH1385 SH1279 SH2125 SH0729 SH1368 USG721 SH1385 SH1997 SH2125 USG294 SH1378 SH1997 SH0035 SG704 SH1385 SH1279 SH1279 SH2125 SH1378 SH1378 SH0495 SH1390 SH1390 SH1385 SH2125 SH1378 SH1385 SH1279 USG721 SH1279 SH1837 USG518 SH1385 SH1378 USG022 SH1378 SH1570 SH1385 SH1385 SH0935 SH0935 SG704 SG704 SH1378 USG022 SH1385 SH1279 USG721 SH1279 USG518 SH1837 SH1279 USG022 SH1385 SH1385 SH1964 SH1385 SH1390 SH1279 SH1964 SH1385 SH1570 USG294 SH1182 SH1279 SH1279 USG022 SH1385 SH0825 USG294 SH0035 SH1276 SH2125 SH1279 RSH0152 USG518 SH1557 SH1837 SH1385 SH1390 SH1279 SH1390 SH1390 USG294 SH1385 SH1279 SH1385 SH1279 SH2125 USG721 SH1837 SH0035 SH1964 SH1837 SH1385 SH1385 SH1279 SH1279 RSH0152 SH1378 SH0495 Material Number: 420207-09 da Vinci System Numbers: RSH0152 SH1378 SH1385 SH1279 USG721 SH1279 SH1378 SH1385 USG721 SH1279 SH1182 SH1390 SH1076 USG721 SH1279 SH1182 SH1385 SH1837 SH1279 SH1837 SH1279 Material Number: 420207-10 da Vinci System Numbers: SH1279 SH1385 SH1390 SH1279 SH1385 SH1182 SH1368 SH1997 SH1279 USG721 SH1822 SH1557 SH1822 SH1964 SH1279 SH0495 SH1390 SH1279 SH1964 USG022 SH1822 SH1378 SH1182 SH1837 SH1279 SH1279 SH1279 SH1279 SH1997 SH1964 SH1964 SH1997 SH0761 SH1279 SH1837 SH1279 SH1279 SH1279 SH1390 SH1279 SH1997

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98408

This product is part of a recall event; the main page for the event is da Vinci S, Si Permanent Cautery Hook Instrument recalled.

Reported	Class	Recall	Company	Reason	Where
8 Apr 2026	CLASS II	da Vinci S, Si Permanent Cautery Hook Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide

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