Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98408

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 09, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Intuitive Surgical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1700-2026
Recall number
Z-1700-2026
Initiated
December 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
2095 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 2 of 2

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

Z-1701-2026
Recall number
Z-1701-2026
Initiated
December 09, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Intuitive Surgical, Inc.
Quantity
6152 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.