Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-1701-2026

Intuitive Surgical, Inc. recalls Brand Name: da Vinci S

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Apr 8, 2026 · 3 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    GTIN 00886874111536
    400 affected lots
    42018300886874111536D088920420183-05USG294SH0059SH0075SH0059
    +392 moreUSG294420183-06SH1378SH1378SH0729SH1182USG294USG294USG294SH1015SH0729USG294SH0825SH1390SG704SH0935SG704USG022SH1182SH0729SH1390SH1276USG294SH1182SG704SH1182SH1276SH1076USG294SH1015SH1076SH1390USG022SH2144SH1182SH0825SH1182SH0547USG689SH1385USG689USG294SH1276SH1076SH1276SH0729SH0059SH1604SH0825USG294SH1276SH1378SH1622SH1182SH0059SH1182SH1276SH1276USG689USG294SH1182SH1276SH1378USG518SH1182SH1570SH1276SH1182SH0035SH0825SH0035SH1837SH1276USG294SH0059SH1368SH1276SH1570SH1378SH1182SH1378SH1378SH0547SH1276SH1276USG518SH1276SH1182SH1015SH0495SH1182SH1390SH1378SH1182SH1276SH0825SH1378SG704SH1378SH1276SH1182SH0547SH0935SH0547SH1622SH1182SH1557USG294SH0495SH1276SH1557SH1276SH1182SH1391SH1276SH1557SH2186SH1182SH1391SH1182SH1997USG294SH1997SH2125SH1276SH2125SH1276SH1182420183-10SH1182SH0825SH1276SH1182SH2125SH1182USG294USG294SH1182SH1182SH0547SH1378SH0495SH1182SH1997SH1182SH1276SH0825USG518SH1182SH1276SH1276SH2125SH0825SH1182SH1182SH1837SH0935SH2144SH0935SH2125SH1182SH1378SH0935SH1276SH1182SH1622SH1390SH2125SH1557SH1182SH1368SH0935SH1557SH1182SH0495SH2125SH0935SH1182SH0547SG704SH1182SH1279SH1557SH0825SH2125SH1076420183-11SH1390SH1182SH2125SH1557SG704SH1015USG294SH1015SH1182SH1182USG294SH1182SH0935SH0935SH1390SH2125SH1182SH1570SH1182SH1015SH2125USG294SH1076SH1378SH1557USG689USG022SH0035SH0059SH1390SH2125SH0935SH1182SH1015SH1182SH1604SH2125SH1182SH1015SH1182SH1622SH1182SH0059SH1015SH1015SH0935SH0935420183-12SH1390SH2125SH1182SH0935SH1182SH0059SH1015SH0935SH2125SH1182USG518USG294SH1182SH2125SH1182SH1570SH1182SH1182SG704SH2125SH1182SH1557SG704SH1182USG294SH1557SH2125USG294SH1182SH1557SH2125SH0935SH0825SH0729SH1182SH1557SH0059SH1622SH1182USG294SH1378SH1557SH2125SH1076SH1822USG294SH1182SH1557SH0825SH1182SH0495SH2125SH1557SH2144SH2125SG704SH0059SH2125SH1604420183-14SH1182SH2125SH1182SH2144SH2144USG294SH1622SH2125SH1182SH1182SH1822SH2125USG721SH0729SH1822SG704SH2125SH0825SH1015SH1182SH1182SH2125SH1997SH1622SH0825SH2186SH2180SH1822SH0729SH1015SH1015SH2144SH1822SH2125USG721SH1182SH1182SH1997USG294SH2186SH1182SH0495SH1997SH1997420183-15SH1182USG721SH1997SH1182SH2125SH1997SH1368SH1822SH2125SH1182USG689SH2144SH1015SH1015SH1964SH1368SH1182SH1015SH1997SH1964SH1015SH1182SH1368SH1182SH1822SH1182SH1964SH2186SH1182SH1182SH1997SH1997SH1964USG294SH1837SH1997420183-15SH1182USG721SH1997SH1182SH2125SH1997SH1368SH1822SH2125SH1182USG689SH2144SH1015SH1015SH1964

What the firm is doing

On 12/29/2025, the firm email and sent via overnight priority mail an "Urgent: Medical Device Recall" letter to customers informing them of possible pitch cable failures on the da Vinci S and Si Tenaculum Forceps and Permanent Cautery Hooks reusable instruments. Customers are instructed to: 1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 2. Please identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service. 3. Please ensure to include the FSCA number ISIFA2025-16-R in your return notes. 4. Credit will be provided based on the number of remaining lives. 5. If affected products were shared or further distributed with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product. 6. Please retain a copy of this letter and the acknowledgement form for your files. 7. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For further information or support, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls