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  "name": "Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  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",
  "description": "FDA recall Z-1699-2026 — Intuitive Surgical, Inc. is recalling Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  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 (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.",
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    "name": "Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  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",
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      "name": "FDA recall Z-1699-2026: Intuitive Surgical, Inc. is recalling Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  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",
      "text": "The FDA logged enforcement record Z-1699-2026: Intuitive Surgical, Inc. is voluntarily recalling Brand Name: da Vinci S, Si Grasping Retractor Instrument  Product Name: da Vinci S, Si Grasping Retractor Instrument  Model/Catalog Number: 420278  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 — 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: 420278: Grasping Retractor GTIN:  00886874111772 FDA Medical Device Listing Number:  D088920  Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761  Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385  Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604  Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1699-2026 as Class II",
      "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.",
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      "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."
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      "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.",
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            "Value": "Intuitive Surgical, Inc.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Due to increased complaints for broken/frayed grip cables for reusable instruments.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2025-12-09",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Lot Code: 420278: Grasping Retractor GTIN:  00886874111772 FDA Medical Device Listing Number:  D088920  Material Number: 420278-04 Batch / System Numbers: M10110613 SH1182 M10120127 SH1182 M10120217 SH1182 M10120829 SH1182 M10130103 SH1182 M10130114 SH1182 M11130404 SH1182 M10130527 SH1182 M10130606 SH1182 M10130909 SH1182 M10130925 SH1182 S10101229 SG704 S10110105 SG704 M10121214 SH0547 M10110118 SH0059 M10110613 SH0059 S10110819 SH0059 M10121122 SH0059 M10121214 SH0059 M10130114 SH0059 M10130220 SH0059 M10130319 SH0059 M11130404 SH0059 M10120912 SH1390 M10130730 USG721 M10130909 USG721 M10110307 SH0729 M10130214 SH0729 M11130404 SH0729 M10130617 SH0729 M10130628 SH0729 M10120127 SH1076 M10130307 SH1279 M10111028 SH0761  Material Number: 420278-06 Batch / System Numbers: M10140115 SH1182 N10140725 SH1182 N10140923 SH1182 N10150324 SH1182 N10150417 SH1182 N10150721 SH1182 N10150608 SH1182 N10150820 SH1182 N10151113 SH1182 N10151214 SH1182 N10151029 SH1182 N10160304 SH1182 N10151201 SH1182 N10141205 SH1182 N10160921 SH1182 N10161123 SH1182 N10170516 SH1182 N10170601 SH1182 N10170921 SH1182 N10171213 SH1182 N10171226 SH1182 N10180417 SH1182 N10140815 SG704 N10150210 SG704 N10150608 SG704 N10160203 SG704 N10170117 SG704 N10170921 SG704 N10170822 SG704 N10171002 SG704 N10171226 SG704 M10140306 SH0059 N10141205 SH0059 N10150605 SH0059 N10170213 SH0059 N10171213 SH0059 N10171117 SH1964 N10180417 SH1964 N10170310 USG294 M10140306 USG721 M10140319 USG721 N10170412 USG721 N10180117 USG721 N10150224 SH1378 N10160203 SH1378 M10140306 SH0729 N10140828 SH0729 N10150330 SH0729 N10150319 SH0729 N10150525 SH0729 N10151020 SH0729 N10160503 SH0729 N10160524 SH0729 N10180417 SH0729 N10141001 SH1076 N10141030 SH1076 N10151211 SH1604 N10160524 SH1604 N10160801 SH1604 N10160921 SH1604 N10171226 SH1604 N10160921 SH1385 N10161010 SH1385 N10161114 SH1385 N10171117 SH1385  Material Number: 420278-07 Batch / System Numbers: N10181219 SH1182 N10180906 SH1182 N10190423 SH1182 N10181114 SH1182 N10180906 SG704 N10180910 USG721 N10181114 SH1604  Material Number: 420278-09 Batch / System Numbers: N10190826 SH1182 N10190515 SH1182 N10190909 SH1182 N10190902 SH1964 N10190826 SH1964 N10190515 SH1964 N10190909 SH1964 N10190826 USG721 N10190902 SH1604",
            "Status": "recorded"
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            "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.",
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