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

da Vinci S, Si Permanent Cautery Hook Instrument recalled

Intuitive Surgical is recalling da Vinci S, Si Permanent Cautery Hook 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: 420183, Permanent Cautery Hook GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294 Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182 Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076 Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935 Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604 Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Numbers: 420183-16 da Vinci System Number: SH1997

Quantity recalled6152 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-1701-2026
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 Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 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

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

Is da Vinci S, Si Permanent Cautery Hook Instrument recalled?

Yes. Intuitive Surgical recalled da Vinci S, Si Permanent Cautery Hook Instrument on 9 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1701-2026.

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: 420183, Permanent Cautery Hook GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05 System Numbers: USG294 SH0059 SH0075 SH0059 USG294 Material Number: 420183-06 da Vinci System Numbers: SH1378 SH1378 SH0729 SH1182 USG294 USG294 USG294 SH1015 SH0729 USG294 SH0825 SH1390 SG704 SH0935 SG704 USG022 SH1182 SH0729 SH1390 SH1276 USG294 SH1182 SG704 SH1182 SH1276 SH1076 USG294 SH1015 SH1076 SH1390 USG022 SH2144 SH1182 SH0825 SH1182 SH0547 USG689 SH1385 USG689 USG294 SH1276 SH1076 SH1276 SH0729 SH0059 SH1604 SH0825 USG294 SH1276 SH1378 SH1622 SH1182 SH0059 SH1182 SH1276 SH1276 USG689 USG294 SH1182 SH1276 SH1378 USG518 SH1182 SH1570 SH1276 SH1182 SH0035 SH0825 SH0035 SH1837 SH1276 USG294 SH0059 SH1368 SH1276 SH1570 SH1378 SH1182 SH1378 SH1378 SH0547 SH1276 SH1276 USG518 SH1276 SH1182 SH1015 SH0495 SH1182 SH1390 SH1378 SH1182 SH1276 SH0825 SH1378 SG704 SH1378 SH1276 SH1182 SH0547 SH0935 SH0547 SH1622 SH1182 SH1557 USG294 SH0495 SH1276 SH1557 SH1276 SH1182 SH1391 SH1276 SH1557 SH2186 SH1182 SH1391 SH1182 SH1997 USG294 SH1997 SH2125 SH1276 SH2125 SH1276 SH1182 Material Number: 420183-10 da Vinci System Numbers: SH1182 SH0825 SH1276 SH1182 SH2125 SH1182 USG294 USG294 SH1182 SH1182 SH0547 SH1378 SH0495 SH1182 SH1997 SH1182 SH1276 SH0825 USG518 SH1182 SH1276 SH1276 SH2125 SH0825 SH1182 SH1182 SH1837 SH0935 SH2144 SH0935 SH2125 SH1182 SH1378 SH0935 SH1276 SH1182 SH1622 SH1390 SH2125 SH1557 SH1182 SH1368 SH0935 SH1557 SH1182 SH0495 SH2125 SH0935 SH1182 SH0547 SG704 SH1182 SH1279 SH1557 SH0825 SH2125 SH1076 Material Number: 420183-11 da Vinci System Numbers: SH1390 SH1182 SH2125 SH1557 SG704 SH1015 USG294 SH1015 SH1182 SH1182 USG294 SH1182 SH0935 SH0935 SH1390 SH2125 SH1182 SH1570 SH1182 SH1015 SH2125 USG294 SH1076 SH1378 SH1557 USG689 USG022 SH0035 SH0059 SH1390 SH2125 SH0935 SH1182 SH1015 SH1182 SH1604 SH2125 SH1182 SH1015 SH1182 SH1622 SH1182 SH0059 SH1015 SH1015 SH0935 SH0935 Material Number: 420183-12 da Vinci System Numbers: SH1390 SH2125 SH1182 SH0935 SH1182 SH0059 SH1015 SH0935 SH2125 SH1182 USG518 USG294 SH1182 SH2125 SH1182 SH1570 SH1182 SH1182 SG704 SH2125 SH1182 SH1557 SG704 SH1182 USG294 SH1557 SH2125 USG294 SH1182 SH1557 SH2125 SH0935 SH0825 SH0729 SH1182 SH1557 SH0059 SH1622 SH1182 USG294 SH1378 SH1557 SH2125 SH1076 SH1822 USG294 SH1182 SH1557 SH0825 SH1182 SH0495 SH2125 SH1557 SH2144 SH2125 SG704 SH0059 SH2125 SH1604 Material Number: 420183-14 da Vinci System Numbers: SH1182 SH2125 SH1182 SH2144 SH2144 USG294 SH1622 SH2125 SH1182 SH1182 SH1822 SH2125 USG721 SH0729 SH1822 SG704 SH2125 SH0825 SH1015 SH1182 SH1182 SH2125 SH1997 SH1622 SH0825 SH2186 SH2180 SH1822 SH0729 SH1015 SH1015 SH2144 SH1822 SH2125 USG721 SH1182 SH1182 SH1997 USG294 SH2186 SH1182 SH0495 SH1997 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Number: 420183-15 da Vinci System Numbers: SH1182 USG721 SH1997 SH1182 SH2125 SH1997 SH1368 SH1822 SH2125 SH1182 USG689 SH2144 SH1015 SH1015 SH1964 SH1368 SH1182 SH1015 SH1997 SH1964 SH1015 SH1182 SH1368 SH1182 SH1822 SH1182 SH1964 SH2186 SH1182 SH1182 SH1997 SH1997 SH1964 USG294 SH1837 SH1997 Material Numbers: 420183-16 da Vinci System Number: 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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