Z-1696-2026.jsonld
type: Dataset
name: Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 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
description: FDA recall Z-1696-2026 — Intuitive Surgical, Inc. is recalling Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 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
  manufacturer: Intuitive Surgical, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1696-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1696-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1696-2026
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Intuitive Surgical, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to increased complaints for broken/frayed grip cables for reusable instruments.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-12-09
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Device Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110217 SH1279 M10110222 SH1279 M10110228 SH0547 M10110228 USG721 M10110228 USG022 M10110228 SH1378 M10110228 SH1279 M10110301 SH1279 M10110303 SH0495 M10110304 USG294 M10110304 SH0729 M10110304 SH0761 M10110307 USG294 M10110308 USG294 M10110308 SH0035 M10110308 SH0495 M10110308 SH1279 M10110311 USG294 M10110311 SH2144 M10110315 USG294 M10110318 USG294 M10110318 SH0935 M10110318 SH1279 M10110323 USG022 M10110324 SH0059 M10110324 USG022 M10110324 SH0495 M10110328 USG294 M10110328 SH0935 M10110328 SH1279 M10110329 USG294 M10110329 SH0935 M10110331 SH0935 M10110405 SH1378 M10110413 USG294 M10110413 SH1279 M10110414 SG704 M10110414 SH0495 M10110420 SH1279 M10110425 SH0035 M10110426 SH0059 M10110428 USG022 M10110429 SG2026 M10110429 SH0035 M10110504 USG294 M10110512 USG294 M10110512 USG022 M10110512 SH2144 M10110517 USG294 M10110517 SH0495 M10110518 SH0035 M10110524 USG294 M10110524 SH1279 M10110525 USG294 M10110526 USG294 M10110526 SH1378 M10110602 SH1279 M10110603 SH1378 M10110614 SH1279 M10110616 SH1368 M10110617 SH1182 M10110617 SH0495 M10110621 SH2144 M10110622 SH0935 M10110623 SH0729 M10110624 SH1378 M10110629 USG294 M10110630 SH1279 M10110630 SH2144 M10110701 SH1378 M10110705 SH0035 M10110711 USG294 M10110712 SH1378 M10110712 SH0495 M10110715 SH1279 M10110715 SH2144 M10110718 SH0761 M10…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1696-2026: Intuitive Surgical, Inc. is recalling Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 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
text: The FDA logged enforcement record Z-1696-2026: Intuitive Surgical, Inc. is voluntarily recalling Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 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 — reason: Due to increased complaints for broken/frayed grip cables for reusable instruments.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-09. Affected lots/codes: Lot Code: 420179: Monopolar Curved Scissors (Hot Shears) GTIN: 00886874111505 FDA Medical Device Number: D088920 Material Number: 420179-10 Batch / System Numbers: M10101102 SH0935 M10101201 SH0935 M10101202 SH1279 M10101203 SH0059 M10101204 USG294 M10101206 USG294 M10101206 SH1378 M10101214 USG022 M10101214 SH0035 M10101214 SH0495 M10110104 SH1279 M10110111 SH1378 M10110112 USG294 M10110113 SH0075 M10110121 SG704 M10110121 SH1279 M10110124 SH0495 M10110126 USG721 M10110126 SH1391 M10110127 USG721 M10110127 SH1279 M10110127 SH2144 M10110202 USG294 M10110202 SH0495 M10110203 SH2144 M10110208 SG704 M10110210 SH1378 M10110216 SH1368 M10110216 USG294 M10110216 SH1391 M10110217 SH0495 M10110…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1696-2026 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.