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  "name": "smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:    1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070;   2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080;   3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090;   4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070;   5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080;   6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090;   7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070;   8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080;   9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090;   10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070;   11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080;   12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090",
  "description": "FDA recall Z-3088-2024 — Smiths Medical ASD Inc. is recalling smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:    1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070;   2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080;   3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090;   4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070;   5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080;   6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090;   7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070;   8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080;   9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090;   10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070;   11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080;   12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090 (Devices, Class I). 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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    "@type": "schema:MedicalDevice",
    "name": "smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:    1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070;   2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080;   3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090;   4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070;   5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080;   6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090;   7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070;   8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080;   9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090;   10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070;   11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080;   12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090",
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      "name": "FDA recall Z-3088-2024: Smiths Medical ASD Inc. is recalling smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:    1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070;   2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080;   3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090;   4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070;   5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080;   6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090;   7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070;   8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080;   9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090;   10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070;   11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080;   12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090",
      "text": "The FDA logged enforcement record Z-3088-2024: Smiths Medical ASD Inc. is voluntarily recalling smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows:    1) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube, Item Number 101/561/070;   2) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube, Item Number 101/561/080;   3) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube, Item Number 101/561/090;   4) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/070;   5) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/080;   6) BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube, Item Number 101/563/090;   7) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/070;   8) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/080;   9) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY), Item Number 101/595/090;   10) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/070;   11) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/080;   12) BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/596/090 — reason: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-07. Affected lots/codes: 101/561/070, Lot Number 3887555;  101/561/070, Lot Number 3928959;  101/561/070, Lot Number 4005346;  101/561/070, Lot Number 4217858;  101/561/070, Lot Number 4234862;  101/561/070, Lot Number 4266405;  101/561/070, Lot Number 4348810;  101/561/080, Lot Number 3887536;  101/561/080, Lot Number 3906566;  101/561/080, Lot Number 3906567;  101/561/080, Lot Number 3906568;  101/561/080, Lot Number 4217859;  101/561/080, Lot Number 4232677;  101/561/080, Lot Number 4238252;  101/561/080, Lot Number 4249230;  101/561/080, Lot Number 4281149;  101/561/080, Lot Number 4281150;  101/561/080, Lot Number 4283700;  101/561/080, Lot Number 4285877;  101/561/080, Lot Number 4288974;  101/561/080, Lot Number 4291189;  101/561/080, Lot Number 4304152;  101/561/080, Lot Number 4308334;  101/561/080, Lot Number 4348877;  101/561/080, Lot Number 4348878;  101/561/080, Lot Number 4348879;  101/561/080, Lot Number 4348883;  101/561/080, Lot Number 4348884;  101/561/080, Lot Number 4348885;  101/561/080, Lot Number 4348886;  101/561/080, Lot Number 4348892;  101/561/080, Lot Number 4348893;  101/561/080, Lot Number 4382035;  101/561/080, Lot Number 4382036;  101/561/080, Lot Number 4382037;  101/561/080, Lot Number 4382038;  101/561/080, Lot Number 4382039;  101/561/080, Lot Number 4382040;  101/561/080, Lot Number 4386515;  101/561/080, Lot Number 4386516;  101/561/080, Lot Number 4386517;  101/561/080, Lot Number 4386518;  101/561/080, Lot Number 4396543;  101/561/080, Lot Number 4396544;  101/561/080, Lot Number 4396545;  101/561/080, Lot Number 4399795;  101/561/080, Lot Number 4399796;  101/561/080, Lot Number 4399797;  101/561/080, Lot Number 4399798;  101/561/080, Lot Number 4399799;  101/561/080, Lot Number 4405137;  101/561/080, Lot Number 4408626;  101/561/080, Lot Number 4412102;  101/561/080, Lot Number 4412103;  101/561/080, Lot Number 4412104;  101/561/080, Lot Number 4415777;  101/561/080, Lot Number 4415778;  101/561/080, Lot Number 4415785;  101/561/090, Lot Number 3887528;  101/561/090, Lot Number 3928993;  101/561/090, Lot Number 3976736;  101/561/090, Lot Number 4170968;  101/561/090, Lot Number 4205592;  101/561/090, Lot Number 4234863;  101/561/090, Lot Number 4242949;  101/561/090, Lot Number 4281078;  101/561/090, Lot Number 4285761;  101/561/090, Lot Number 4310484;  101/561/090, Lot Number 4310485;  101/561/090, Lot Number 4310486;  101/561/090, Lot Number 4310487;  101/561/090, Lot Number 4310488;  101/561/090, Lot Number 4382032;  101/561/090, Lot Number 4382034;  101/561/090, Lot Number 4397559;  101/561/090, Lot Number 4397560;  101/561/090, Lot Number 4415811;  101/561/090, Lot Number 4439066;  101/561/090, Lot Number 4450465;  101/563/070, Lot Number 3887520;  101/563/070, Lot Number 3925814;  101/563/070, Lot Number 3948836;  101/563/070, Lot Number 3965003;  101/563/070, Lot Number 4010058;  101/563/070, Lot Number 4017238;  101/563/070, Lot Number 4054722;  101/563/070, Lot Number 4054723;  101/563/070, Lot Number 4054801;  101/563/070, Lot Number 4165746;  101/563/070, Lot Number 4234758;  101/563/070, Lot Number 4245279;  101/563/070, Lot Number 4249227;  101/563/070, Lot Number 4281148;  101/563/080, Lot Number 3887521;  101/563/080, Lot Number 3910412;  101/563/080, Lot Number 3925815;  101/563/080, Lot Number 3952030;  101/563/080, Lot Number 4009963;  101/563/080, Lot Number 4054725;  101/563/080, Lot Number 4054726;  101/563/080, Lot Number 4061095;  101/563/080, Lot Number 4070503;  101/563/080, Lot Number 4070504;  101/563/080, Lot Number 4073772;  101/563/080, Lot Number 4100287;  101/563/080, Lot Number 4100288;  101/563/080, Lot Number 4103806;  101/563/080, Lot Number 4115434;  101/563/080, Lot Number 4147040;  101/563/080, Lot Number 4149715;  101/563/080, Lot Number 4156960;  101/563/080, Lot Number 4175503;  101/563/080, Lot Number 4199278;  101/563/080, Lot Number 4205593;  101/563/080, Lot Number 4208994;  101/563/080, Lot Number 4217863;  101/563/080, Lot Number 4224557;  101/563/080, Lot Number 4234759;  101/563/080, Lot Number 4281042;  101/563/080, Lot Number 4283716;  101/563/080, Lot Number 4283717;  101/563/080, Lot Number 4283718;  101/563/080, Lot Number 4285933;  101/563/080, Lot Number 4285934;  101/563/080, Lot Number 4285935;  101/563/080, Lot Number 4285936;  101/563/080, Lot Number 4348839;  101/563/080, Lot Number 4348840;  101/563/080, Lot Number 4348841;  101/563/080, Lot Number 4348845;  101/563/080, Lot Number 4348847;  101/563/080, Lot Number 4348848;  101/563/080, Lot Number 4348849;  101/563/080, Lot Number 4348850;  101/563/080, Lot Number 4348851;  101/563/080, Lot Number 4348857;  101/563/080, Lot Number 4348858;  101/563/080, Lot Number 4348859;  101/563/080, Lot Number 4348860;  101/563/080, Lot Number 4350944;  101/563/080, Lot Number 4350945;  101/563/080, Lot Number 4354160;  101/563/080, Lot Number 4385041;  101/563/080, Lot Number 4385042;  101/563/080, Lot Number 4385043;  101/563/080, Lot Number 4385046;  101/563/080, Lot Number 4385047;  101/563/080, Lot Number 4385048;  101/563/080, Lot Number 4385049;  101/563/080, Lot Number 4385050;  101/563/080, Lot Number 4385051;  101/563/080, Lot Number 4385052;  101/563/080, Lot Number 4396414;  101/563/080, Lot Number 4396415;  101/563/080, Lot Number 4396416;  101/563/080, Lot Number 4396419;  101/563/080, Lot Number 4396420;  101/563/080, Lot Number 4396534;  101/563/080, Lot Number 4396535;  101/563/080, Lot Number 4396536;  101/563/080, Lot Number 4396537;  101/563/090, Lot Number 3913653;  101/563/090, Lot Number 3925768;  101/563/090, Lot Number 3980266;  101/563/090, Lot Number 4009974;  101/563/090, Lot Number 4061111;  101/563/090, Lot Number 4094349;  101/563/090, Lot Number 4106839;  101/563/090, Lot Number 4115435;  101/563/090, Lot Number 4156962;  101/563/090, Lot Number 4170970;  101/563/090, Lot Number 4212065;  101/563/090, Lot Number 4227249;  101/563/090, Lot Number 4238178;  101/563/090, Lot Number 4281031;  101/563/090, Lot Number 4348865;  101/563/090, Lot Number 4348866;  101/563/090, Lot Number 4348867;  101/563/090, Lot Number 4386559;  101/563/090, Lot Number 4408641;  101/563/090, Lot Number 4412148;  101/595/070, Lot Number 3898766;  101/595/070, Lot Number 4002180;  101/595/070, Lot Number 4008828;  101/595/070, Lot Number 4032081;  101/595/070, Lot Number 4060523;  101/595/070, Lot Number 4086681;  101/595/070, Lot Number 4168564;  101/595/070, Lot Number 4234424;  101/595/070, Lot Number 4242669;  101/595/070, Lot Number 4256056;  101/595/070, Lot Number 4280697;  101/595/070, Lot Number 4293992;  101/595/070, Lot Number 4324235;  101/595/070, Lot Number 4333064;  101/595/070, Lot Number 4352941;  101/595/070, Lot Number 4415588;  101/595/070, Lot Number 4415609;  101/595/070, Lot Number 4423960;  101/595/080, Lot Number 3898767;  101/595/080, Lot Number 3950077;  101/595/080, Lot Number 3950078;  101/595/080, Lot Number 3987811;  101/595/080, Lot Number 3991671;  101/595/080, Lot Number 4008820;  101/595/080, Lot Number 4032077;  101/595/080, Lot Number 4032079;  101/595/080, Lot Number 4060526;  101/595/080, Lot Number 4072732;  101/595/080, Lot Number 4086680;  101/595/080, Lot Number 4098486;  101/595/080, Lot Number 4110835;  101/595/080, Lot Number 4128476;  101/595/080, Lot Number 4131412;  101/595/080, Lot Number 4148995;  101/595/080, Lot Number 4163147;  101/595/080, Lot Number 4179977;  101/595/080, Lot Number 4256035;  101/595/080, Lot Number 4259012;  101/595/080, Lot Number 4265777;  101/595/080, Lot Number 4272986;  101/595/080, Lot Number 4283836;  101/595/080, Lot Number 4296804;  101/595/080, Lot Number 4324236;  101/595/080, Lot Number 4326879;  101/595/080, Lot Number 4330616;  101/595/080, Lot Number 4339190;  101/595/080, Lot Number 4341351;  101/595/080, Lot Number 4425478;  101/595/090, Lot Number 3898768;  101/595/090, Lot Number 3944042;  101/595/090, Lot Number 3950056;  101/595/090, Lot Number 3987809;  101/595/090, Lot Number 4008834;  101/595/090, Lot Number 4008836;  101/595/090, Lot Number 4036473;  101/595/090, Lot Number 4036503;  101/595/090, Lot Number 4060529;  101/595/090, Lot Number 4098459;  101/595/090, Lot Number 4110836;  101/595/090, Lot Number 4168614;  101/595/090, Lot Number 4177105;  101/595/090, Lot Number 4183504;  101/595/090, Lot Number 4263406;  101/595/090, Lot Number 4265778;  101/595/090, Lot Number 4291330;  101/595/090, Lot Number 4294002;  101/595/090, Lot Number 4324771;  101/595/090, Lot Number 4330618;  101/595/090, Lot Number 4344183;  101/595/090, Lot Number 4423957;  101/596/070, Lot Number 3944058;  101/596/070, Lot Number 3967805;  101/596/070, Lot Number 4008830;  101/596/070, Lot Number 4060560;  101/596/070, Lot Number 4098464;  101/596/070, Lot Number 4116821;  101/596/070, Lot Number 4123503;  101/596/070, Lot Number 4134674;  101/596/070, Lot Number 4240514;  101/596/070, Lot Number 4241327;  101/596/070, Lot Number 4263399;  101/596/070, Lot Number 4275910;  101/596/070, Lot Number 4285358;  101/596/070, Lot Number 4415589;  101/596/070, Lot Number 4423966;  101/596/070, Lot Number 4428303;  101/596/080, Lot Number 3898770;  101/596/080, Lot Number 3979602;  101/596/080, Lot Number 3979615;  101/596/080, Lot Number 4008832;  101/596/080, Lot Number 4036527;  101/596/080, Lot Number 4060531;  101/596/080, Lot Number 4069871;  101/596/080, Lot Number 4101970;  101/596/080, Lot Number 4110837;  101/596/080, Lot Number 4119536;  101/596/080, Lot Number 4131437;  101/596/080, Lot Number 4146207;  101/596/080, Lot Number 4179935;  101/596/080, Lot Number 4241328;  101/596/080, Lot Number 4246523;  101/596/080, Lot Number 4252236;  101/596/080, Lot Number 4256036;  101/596/080, Lot Number 4268459;  101/596/080, Lot Number 4307794;  101/596/080, Lot Number 4415596;  101/596/080, Lot Number 4436549;  101/596/090, Lot Number 3944050;  101/596/090, Lot Number 3950088;  101/596/090, Lot Number 4008815;  101/596/090, Lot Number 4032080;  101/596/090, Lot Number 4060533;  101/596/090, Lot Number 4098449;  101/596/090, Lot Number 4101971;  101/596/090, Lot Number 4119537;  101/596/090, Lot Number 4123504;  101/596/090, Lot Number 4261158;  101/596/090, Lot Number 4263403;  101/596/090, Lot Number 4270589;  101/596/090, Lot Number 4280743;  101/596/090, Lot Number 4285393;  101/596/090, Lot Number 4301196;  101/596/090, Lot Number 4319347;  101/596/090, Lot Number 4326871;  101/596/090, Lot Number 4423968;  101/596/090, Lot Number 4436550;  101/596/090, Lot Number 4447674;  101/596/090, Lot Number 4459709. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-3088-2024&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-3088-2024&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-3088-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3088-2024 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "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-3088-2024&lang=eng",
        "value": "Class I",
        "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-3088-2024&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-3088-2024/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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
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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": "There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.",
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            "Field": "Initiated",
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