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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1989-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Prestige Coil System REFs/UDI-DI codes:  PRES0153CXPPLT\t00810068567311  PRES1045CPKPLT\t00810068567663  PRES1245CPKPLT\t00810068567694  PRES1445CPKPLT\t00810068567724  PRES0103CXPPLT\t00810068567304  PRES2512CXPPLT\t00810068567397  PRES0258CXPPLT\t00810068567380  PRES0212CXPPLT\t00810068567373  PRES0204CXPPLT\t00810068567342  PRES0206CXPPLT\t00810068567359  PRES0208CXPPLT\t00810068567366  PRES3520CXPPLT\t00810068567441  PRES3530CXPPLT\t00810068567458  PRES0310CXPPLT\t00810068567403  PRES0320CXPPLT\t00810068567410  PRES0420CPKPLT\t00810068567489  PRES0517CPKPLT\t00810068567519  PRES0540CPKPLT\t00810068568028  PRES0620CPKPLT\t00810068567557  PRES0635CPKPLT\t00810068567564  PRES0650CPKPLT\t00810068567571  PRES0720CPKPLT\t00810068567588  PRES0735CPKPLT\t00810068567595  PRES0750CPKPLT\t00810068567601  PRES0830CPKPLT\t00810068567618  PRES0845CPKPLT\t00810068567625  PRES0153HXPPL\t00818053027147  PRES0204HXPPL\t00818053029943  PRES0204CXPPL\t00818053027321  PRES0208HXPPL\t00818053029981  PRES0315HXPPL\t00818053027178  PRES0307CXPPL\t00818053027376  PRES0420HPKPL\t00818053027185  PRES0440HPKPL\t00810068567830  PRES0520HPKPL\t00818053027192  PRES0540HPKPL\t00810068567847  PRES0650HPKPL\t00810068567854  PRES0720HPKPL\t00818053027215  PRES0750HPKPL\t00810068567861  PRES0830HPKPL\t00818053027222    The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.",
  "description": "FDA recall Z-1989-2025 — BALT USA, LLC is recalling Prestige Coil System REFs/UDI-DI codes:  PRES0153CXPPLT\t00810068567311  PRES1045CPKPLT\t00810068567663  PRES1245CPKPLT\t00810068567694  PRES1445CPKPLT\t00810068567724  PRES0103CXPPLT\t00810068567304  PRES2512CXPPLT\t00810068567397  PRES0258CXPPLT\t00810068567380  PRES0212CXPPLT\t00810068567373  PRES0204CXPPLT\t00810068567342  PRES0206CXPPLT\t00810068567359  PRES0208CXPPLT\t00810068567366  PRES3520CXPPLT\t00810068567441  PRES3530CXPPLT\t00810068567458  PRES0310CXPPLT\t00810068567403  PRES0320CXPPLT\t00810068567410  PRES0420CPKPLT\t00810068567489  PRES0517CPKPLT\t00810068567519  PRES0540CPKPLT\t00810068568028  PRES0620CPKPLT\t00810068567557  PRES0635CPKPLT\t00810068567564  PRES0650CPKPLT\t00810068567571  PRES0720CPKPLT\t00810068567588  PRES0735CPKPLT\t00810068567595  PRES0750CPKPLT\t00810068567601  PRES0830CPKPLT\t00810068567618  PRES0845CPKPLT\t00810068567625  PRES0153HXPPL\t00818053027147  PRES0204HXPPL\t00818053029943  PRES0204CXPPL\t00818053027321  PRES0208HXPPL\t00818053029981  PRES0315HXPPL\t00818053027178  PRES0307CXPPL\t00818053027376  PRES0420HPKPL\t00818053027185  PRES0440HPKPL\t00810068567830  PRES0520HPKPL\t00818053027192  PRES0540HPKPL\t00810068567847  PRES0650HPKPL\t00810068567854  PRES0720HPKPL\t00818053027215  PRES0750HPKPL\t00810068567861  PRES0830HPKPL\t00818053027222    The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. (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/",
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  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1989-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Prestige Coil System REFs/UDI-DI codes:  PRES0153CXPPLT\t00810068567311  PRES1045CPKPLT\t00810068567663  PRES1245CPKPLT\t00810068567694  PRES1445CPKPLT\t00810068567724  PRES0103CXPPLT\t00810068567304  PRES2512CXPPLT\t00810068567397  PRES0258CXPPLT\t00810068567380  PRES0212CXPPLT\t00810068567373  PRES0204CXPPLT\t00810068567342  PRES0206CXPPLT\t00810068567359  PRES0208CXPPLT\t00810068567366  PRES3520CXPPLT\t00810068567441  PRES3530CXPPLT\t00810068567458  PRES0310CXPPLT\t00810068567403  PRES0320CXPPLT\t00810068567410  PRES0420CPKPLT\t00810068567489  PRES0517CPKPLT\t00810068567519  PRES0540CPKPLT\t00810068568028  PRES0620CPKPLT\t00810068567557  PRES0635CPKPLT\t00810068567564  PRES0650CPKPLT\t00810068567571  PRES0720CPKPLT\t00810068567588  PRES0735CPKPLT\t00810068567595  PRES0750CPKPLT\t00810068567601  PRES0830CPKPLT\t00810068567618  PRES0845CPKPLT\t00810068567625  PRES0153HXPPL\t00818053027147  PRES0204HXPPL\t00818053029943  PRES0204CXPPL\t00818053027321  PRES0208HXPPL\t00818053029981  PRES0315HXPPL\t00818053027178  PRES0307CXPPL\t00818053027376  PRES0420HPKPL\t00818053027185  PRES0440HPKPL\t00810068567830  PRES0520HPKPL\t00818053027192  PRES0540HPKPL\t00810068567847  PRES0650HPKPL\t00810068567854  PRES0720HPKPL\t00818053027215  PRES0750HPKPL\t00810068567861  PRES0830HPKPL\t00818053027222    The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "BALT USA, LLC"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1989-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1989-2025: BALT USA, LLC is recalling Prestige Coil System REFs/UDI-DI codes:  PRES0153CXPPLT\t00810068567311  PRES1045CPKPLT\t00810068567663  PRES1245CPKPLT\t00810068567694  PRES1445CPKPLT\t00810068567724  PRES0103CXPPLT\t00810068567304  PRES2512CXPPLT\t00810068567397  PRES0258CXPPLT\t00810068567380  PRES0212CXPPLT\t00810068567373  PRES0204CXPPLT\t00810068567342  PRES0206CXPPLT\t00810068567359  PRES0208CXPPLT\t00810068567366  PRES3520CXPPLT\t00810068567441  PRES3530CXPPLT\t00810068567458  PRES0310CXPPLT\t00810068567403  PRES0320CXPPLT\t00810068567410  PRES0420CPKPLT\t00810068567489  PRES0517CPKPLT\t00810068567519  PRES0540CPKPLT\t00810068568028  PRES0620CPKPLT\t00810068567557  PRES0635CPKPLT\t00810068567564  PRES0650CPKPLT\t00810068567571  PRES0720CPKPLT\t00810068567588  PRES0735CPKPLT\t00810068567595  PRES0750CPKPLT\t00810068567601  PRES0830CPKPLT\t00810068567618  PRES0845CPKPLT\t00810068567625  PRES0153HXPPL\t00818053027147  PRES0204HXPPL\t00818053029943  PRES0204CXPPL\t00818053027321  PRES0208HXPPL\t00818053029981  PRES0315HXPPL\t00818053027178  PRES0307CXPPL\t00818053027376  PRES0420HPKPL\t00818053027185  PRES0440HPKPL\t00810068567830  PRES0520HPKPL\t00818053027192  PRES0540HPKPL\t00810068567847  PRES0650HPKPL\t00810068567854  PRES0720HPKPL\t00818053027215  PRES0750HPKPL\t00810068567861  PRES0830HPKPL\t00818053027222    The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.",
      "text": "The FDA logged enforcement record Z-1989-2025: BALT USA, LLC is voluntarily recalling Prestige Coil System REFs/UDI-DI codes:  PRES0153CXPPLT\t00810068567311  PRES1045CPKPLT\t00810068567663  PRES1245CPKPLT\t00810068567694  PRES1445CPKPLT\t00810068567724  PRES0103CXPPLT\t00810068567304  PRES2512CXPPLT\t00810068567397  PRES0258CXPPLT\t00810068567380  PRES0212CXPPLT\t00810068567373  PRES0204CXPPLT\t00810068567342  PRES0206CXPPLT\t00810068567359  PRES0208CXPPLT\t00810068567366  PRES3520CXPPLT\t00810068567441  PRES3530CXPPLT\t00810068567458  PRES0310CXPPLT\t00810068567403  PRES0320CXPPLT\t00810068567410  PRES0420CPKPLT\t00810068567489  PRES0517CPKPLT\t00810068567519  PRES0540CPKPLT\t00810068568028  PRES0620CPKPLT\t00810068567557  PRES0635CPKPLT\t00810068567564  PRES0650CPKPLT\t00810068567571  PRES0720CPKPLT\t00810068567588  PRES0735CPKPLT\t00810068567595  PRES0750CPKPLT\t00810068567601  PRES0830CPKPLT\t00810068567618  PRES0845CPKPLT\t00810068567625  PRES0153HXPPL\t00818053027147  PRES0204HXPPL\t00818053029943  PRES0204CXPPL\t00818053027321  PRES0208HXPPL\t00818053029981  PRES0315HXPPL\t00818053027178  PRES0307CXPPL\t00818053027376  PRES0420HPKPL\t00818053027185  PRES0440HPKPL\t00810068567830  PRES0520HPKPL\t00818053027192  PRES0540HPKPL\t00810068567847  PRES0650HPKPL\t00810068567854  PRES0720HPKPL\t00818053027215  PRES0750HPKPL\t00810068567861  PRES0830HPKPL\t00818053027222    The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. — reason: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-05-08. Affected lots/codes: Product Description/Product Catalog Number/UDI-DI/Lot Numbers: PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800576 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800947 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800549 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800759 PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0258CXPPLT 00810068567380 F230800833 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800515 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800527 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800578 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800791 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800941 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800454 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800546 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800771 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800888 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800479 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800580 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800715 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800938 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F241100052 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800940 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800949 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800418 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800529 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800482 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800483 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800769 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800504 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800763 PRES0320CXPPLT Prestige 3mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0320CXPPLT 00810068567410 F230800441 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800795 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800796 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800451 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800664 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800797 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800831 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800822 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800886 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F241200132 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800458 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800517 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800511 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800519 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800766 PRES0650CPKPLT Prestige 6mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0650CPKPLT 00810068567571 F230800821 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800440 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800510 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800518 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800537 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800818 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230900021 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800444 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800509 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800665 PRES0830CPKPLT Prestige 8mm x 30cm (Ver. T) Prestige Plus Complex Pack PRES0830CPKPLT 00810068567618 F230800516 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800486 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. 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A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1989-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1989-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1989-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1989-2025 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1989-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1989-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1989-2025/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
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      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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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          "item": {
            "Field": "Recalling firm",
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.",
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          "item": {
            "Field": "Initiated",
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            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, India, Indonesia, Iraq, Italy, Japan, Jordan, Kazakhstan, Korea, Kyrgyzstan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Uruguay, and Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}