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  "name": "8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿    REF 470230",
  "description": "FDA recall Z-0861-2025 — Intuitive Surgical, Inc. is recalling 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿    REF 470230 (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0861-2025/enforcement-record",
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      "name": "FDA recall Z-0861-2025: Intuitive Surgical, Inc. is recalling 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿    REF 470230",
      "text": "The FDA logged enforcement record Z-0861-2025: Intuitive Surgical, Inc. is voluntarily recalling 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿    REF 470230 — reason: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-19. Affected lots/codes: Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108  Model Number: 470230 Part Number: 470230-14 UDI-DI code: 00886874112380 Batch Numbers: K10230914. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0861-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-0861-2025 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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        "value": "Class II",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0861-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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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      "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."
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            "Field": "Reason",
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            "Field": "Initiated",
            "Value": "2024-12-19",
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            "Value": "Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108  Model Number: 470230 Part Number: 470230-14 UDI-DI code: 00886874112380 Batch Numbers: K10230914",
            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico.  O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam",
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