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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1890-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ADD A ENDOVASCULAR PACK-LF\tDYNJ0429339L, DYNJ0429339M  \t  ANGIO ARTERIOGRAM PACK-LF\tDYNJ0774026K  \t  ANGIO KIT PACK\tDYNJ83746B  \t  ANGIO TRAY NO LIDO\tDYNJ85557A  \t  ANGIOGRAPHY PACK II\tDYNJ17218S, DYNJ17218T    ARTERIOGRAM NEURO PACK-LF\tDYNJ0842499L  \t  ARTERIOGRAM PACK-LF\tDYNJ0842478M  \t  CARDIAC CATH II PK\tDYNJ21259O  \t  CARDIAC CATH PACK\tDYNJ68653D  \t  CATH LAB ANGIOGRAPHY PACK\tDYNJ50779G  \t  CATH LAB-LF\tDYNJ51423G  \t  CRANIOTOMY PACK-LF\tDYNJ0101292I  \t  DEEP BRAIN STIMULATION PACK\tDYNJ0842793I  \t  ENDO VASCULAR MINOR\tDYNJ87263  \t  GENERAL ENDO PACK-LF\tDYNJ0842873L  \t  LEFT HEART\tDYNJ45984J  \t  LIPO PACK\tDYNJ87218  \t  MAA Y90 TRAY\tDYNJ82191D  \t  MAIN OR CATH LAB\tDYNJ61373B  \t  MINIMALLY INVASIVE PACK-LF\tDYNJ0843063M  \t  NEURO CERVICAL PACK\tDYNJ0101287M  \t  NEURO RADIOLOGY RICHMOND\tDYNJ68365F  \t  NEURO VP SHUNT PACK-LF\tDYNJ0843121L  \t  NON-VASCULAR PACK\tDYNJ56386C, DYNJ56386D  \t  OR ANGIOGRAM PACK-LF\tDYNJ83656A, DYNJ83656B  \t  OR RADIOLOGY PACK\tDYNJ62747A  \t  PERCUTANEOUS ARTERIAL CATH PK\tDYNJ30551J  \t  PERIPHERAL ARTERIOGRAM RAD\tDYNJ61383C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005I  \t  PICC TRAY\tDYNJ30554I  \t  PODIATRY PACK\tDYNJ46333G  \t  POSTERIOR SPINE PACK-LF\tDYNJ0843339P  \t  RRMC ANGIO PACK\tDYNJ36338D  \t  SPECIAL PROCEDURE PACK\tDYNJ88258  \t  VASCULAR ACCESS PACK-LF\tDYNJ0101291G  \t  VASCULAR HYBRID\tDYNJ57543K  \t  VASCULAR PACK\tDYNJ82220D  \t  VISCERAL ANGIOGRAM PACK-LF\tDYNJ0429121M  \t  WPH EP PACK\tDYNJ62745A",
  "description": "FDA recall Z-1890-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ADD A ENDOVASCULAR PACK-LF\tDYNJ0429339L, DYNJ0429339M  \t  ANGIO ARTERIOGRAM PACK-LF\tDYNJ0774026K  \t  ANGIO KIT PACK\tDYNJ83746B  \t  ANGIO TRAY NO LIDO\tDYNJ85557A  \t  ANGIOGRAPHY PACK II\tDYNJ17218S, DYNJ17218T    ARTERIOGRAM NEURO PACK-LF\tDYNJ0842499L  \t  ARTERIOGRAM PACK-LF\tDYNJ0842478M  \t  CARDIAC CATH II PK\tDYNJ21259O  \t  CARDIAC CATH PACK\tDYNJ68653D  \t  CATH LAB ANGIOGRAPHY PACK\tDYNJ50779G  \t  CATH LAB-LF\tDYNJ51423G  \t  CRANIOTOMY PACK-LF\tDYNJ0101292I  \t  DEEP BRAIN STIMULATION PACK\tDYNJ0842793I  \t  ENDO VASCULAR MINOR\tDYNJ87263  \t  GENERAL ENDO PACK-LF\tDYNJ0842873L  \t  LEFT HEART\tDYNJ45984J  \t  LIPO PACK\tDYNJ87218  \t  MAA Y90 TRAY\tDYNJ82191D  \t  MAIN OR CATH LAB\tDYNJ61373B  \t  MINIMALLY INVASIVE PACK-LF\tDYNJ0843063M  \t  NEURO CERVICAL PACK\tDYNJ0101287M  \t  NEURO RADIOLOGY RICHMOND\tDYNJ68365F  \t  NEURO VP SHUNT PACK-LF\tDYNJ0843121L  \t  NON-VASCULAR PACK\tDYNJ56386C, DYNJ56386D  \t  OR ANGIOGRAM PACK-LF\tDYNJ83656A, DYNJ83656B  \t  OR RADIOLOGY PACK\tDYNJ62747A  \t  PERCUTANEOUS ARTERIAL CATH PK\tDYNJ30551J  \t  PERIPHERAL ARTERIOGRAM RAD\tDYNJ61383C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005I  \t  PICC TRAY\tDYNJ30554I  \t  PODIATRY PACK\tDYNJ46333G  \t  POSTERIOR SPINE PACK-LF\tDYNJ0843339P  \t  RRMC ANGIO PACK\tDYNJ36338D  \t  SPECIAL PROCEDURE PACK\tDYNJ88258  \t  VASCULAR ACCESS PACK-LF\tDYNJ0101291G  \t  VASCULAR HYBRID\tDYNJ57543K  \t  VASCULAR PACK\tDYNJ82220D  \t  VISCERAL ANGIOGRAM PACK-LF\tDYNJ0429121M  \t  WPH EP PACK\tDYNJ62745A (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1890-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ADD A ENDOVASCULAR PACK-LF\tDYNJ0429339L, DYNJ0429339M  \t  ANGIO ARTERIOGRAM PACK-LF\tDYNJ0774026K  \t  ANGIO KIT PACK\tDYNJ83746B  \t  ANGIO TRAY NO LIDO\tDYNJ85557A  \t  ANGIOGRAPHY PACK II\tDYNJ17218S, DYNJ17218T    ARTERIOGRAM NEURO PACK-LF\tDYNJ0842499L  \t  ARTERIOGRAM PACK-LF\tDYNJ0842478M  \t  CARDIAC CATH II PK\tDYNJ21259O  \t  CARDIAC CATH PACK\tDYNJ68653D  \t  CATH LAB ANGIOGRAPHY PACK\tDYNJ50779G  \t  CATH LAB-LF\tDYNJ51423G  \t  CRANIOTOMY PACK-LF\tDYNJ0101292I  \t  DEEP BRAIN STIMULATION PACK\tDYNJ0842793I  \t  ENDO VASCULAR MINOR\tDYNJ87263  \t  GENERAL ENDO PACK-LF\tDYNJ0842873L  \t  LEFT HEART\tDYNJ45984J  \t  LIPO PACK\tDYNJ87218  \t  MAA Y90 TRAY\tDYNJ82191D  \t  MAIN OR CATH LAB\tDYNJ61373B  \t  MINIMALLY INVASIVE PACK-LF\tDYNJ0843063M  \t  NEURO CERVICAL PACK\tDYNJ0101287M  \t  NEURO RADIOLOGY RICHMOND\tDYNJ68365F  \t  NEURO VP SHUNT PACK-LF\tDYNJ0843121L  \t  NON-VASCULAR PACK\tDYNJ56386C, DYNJ56386D  \t  OR ANGIOGRAM PACK-LF\tDYNJ83656A, DYNJ83656B  \t  OR RADIOLOGY PACK\tDYNJ62747A  \t  PERCUTANEOUS ARTERIAL CATH PK\tDYNJ30551J  \t  PERIPHERAL ARTERIOGRAM RAD\tDYNJ61383C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005I  \t  PICC TRAY\tDYNJ30554I  \t  PODIATRY PACK\tDYNJ46333G  \t  POSTERIOR SPINE PACK-LF\tDYNJ0843339P  \t  RRMC ANGIO PACK\tDYNJ36338D  \t  SPECIAL PROCEDURE PACK\tDYNJ88258  \t  VASCULAR ACCESS PACK-LF\tDYNJ0101291G  \t  VASCULAR HYBRID\tDYNJ57543K  \t  VASCULAR PACK\tDYNJ82220D  \t  VISCERAL ANGIOGRAM PACK-LF\tDYNJ0429121M  \t  WPH EP PACK\tDYNJ62745A",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1890-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1890-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ADD A ENDOVASCULAR PACK-LF\tDYNJ0429339L, DYNJ0429339M  \t  ANGIO ARTERIOGRAM PACK-LF\tDYNJ0774026K  \t  ANGIO KIT PACK\tDYNJ83746B  \t  ANGIO TRAY NO LIDO\tDYNJ85557A  \t  ANGIOGRAPHY PACK II\tDYNJ17218S, DYNJ17218T    ARTERIOGRAM NEURO PACK-LF\tDYNJ0842499L  \t  ARTERIOGRAM PACK-LF\tDYNJ0842478M  \t  CARDIAC CATH II PK\tDYNJ21259O  \t  CARDIAC CATH PACK\tDYNJ68653D  \t  CATH LAB ANGIOGRAPHY PACK\tDYNJ50779G  \t  CATH LAB-LF\tDYNJ51423G  \t  CRANIOTOMY PACK-LF\tDYNJ0101292I  \t  DEEP BRAIN STIMULATION PACK\tDYNJ0842793I  \t  ENDO VASCULAR MINOR\tDYNJ87263  \t  GENERAL ENDO PACK-LF\tDYNJ0842873L  \t  LEFT HEART\tDYNJ45984J  \t  LIPO PACK\tDYNJ87218  \t  MAA Y90 TRAY\tDYNJ82191D  \t  MAIN OR CATH LAB\tDYNJ61373B  \t  MINIMALLY INVASIVE PACK-LF\tDYNJ0843063M  \t  NEURO CERVICAL PACK\tDYNJ0101287M  \t  NEURO RADIOLOGY RICHMOND\tDYNJ68365F  \t  NEURO VP SHUNT PACK-LF\tDYNJ0843121L  \t  NON-VASCULAR PACK\tDYNJ56386C, DYNJ56386D  \t  OR ANGIOGRAM PACK-LF\tDYNJ83656A, DYNJ83656B  \t  OR RADIOLOGY PACK\tDYNJ62747A  \t  PERCUTANEOUS ARTERIAL CATH PK\tDYNJ30551J  \t  PERIPHERAL ARTERIOGRAM RAD\tDYNJ61383C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005I  \t  PICC TRAY\tDYNJ30554I  \t  PODIATRY PACK\tDYNJ46333G  \t  POSTERIOR SPINE PACK-LF\tDYNJ0843339P  \t  RRMC ANGIO PACK\tDYNJ36338D  \t  SPECIAL PROCEDURE PACK\tDYNJ88258  \t  VASCULAR ACCESS PACK-LF\tDYNJ0101291G  \t  VASCULAR HYBRID\tDYNJ57543K  \t  VASCULAR PACK\tDYNJ82220D  \t  VISCERAL ANGIOGRAM PACK-LF\tDYNJ0429121M  \t  WPH EP PACK\tDYNJ62745A",
      "text": "The FDA logged enforcement record Z-1890-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes    ADD A ENDOVASCULAR PACK-LF\tDYNJ0429339L, DYNJ0429339M  \t  ANGIO ARTERIOGRAM PACK-LF\tDYNJ0774026K  \t  ANGIO KIT PACK\tDYNJ83746B  \t  ANGIO TRAY NO LIDO\tDYNJ85557A  \t  ANGIOGRAPHY PACK II\tDYNJ17218S, DYNJ17218T    ARTERIOGRAM NEURO PACK-LF\tDYNJ0842499L  \t  ARTERIOGRAM PACK-LF\tDYNJ0842478M  \t  CARDIAC CATH II PK\tDYNJ21259O  \t  CARDIAC CATH PACK\tDYNJ68653D  \t  CATH LAB ANGIOGRAPHY PACK\tDYNJ50779G  \t  CATH LAB-LF\tDYNJ51423G  \t  CRANIOTOMY PACK-LF\tDYNJ0101292I  \t  DEEP BRAIN STIMULATION PACK\tDYNJ0842793I  \t  ENDO VASCULAR MINOR\tDYNJ87263  \t  GENERAL ENDO PACK-LF\tDYNJ0842873L  \t  LEFT HEART\tDYNJ45984J  \t  LIPO PACK\tDYNJ87218  \t  MAA Y90 TRAY\tDYNJ82191D  \t  MAIN OR CATH LAB\tDYNJ61373B  \t  MINIMALLY INVASIVE PACK-LF\tDYNJ0843063M  \t  NEURO CERVICAL PACK\tDYNJ0101287M  \t  NEURO RADIOLOGY RICHMOND\tDYNJ68365F  \t  NEURO VP SHUNT PACK-LF\tDYNJ0843121L  \t  NON-VASCULAR PACK\tDYNJ56386C, DYNJ56386D  \t  OR ANGIOGRAM PACK-LF\tDYNJ83656A, DYNJ83656B  \t  OR RADIOLOGY PACK\tDYNJ62747A  \t  PERCUTANEOUS ARTERIAL CATH PK\tDYNJ30551J  \t  PERIPHERAL ARTERIOGRAM RAD\tDYNJ61383C  \t  PICC ABSCESS PACK-LF\tDYNJ0774005I  \t  PICC TRAY\tDYNJ30554I  \t  PODIATRY PACK\tDYNJ46333G  \t  POSTERIOR SPINE PACK-LF\tDYNJ0843339P  \t  RRMC ANGIO PACK\tDYNJ36338D  \t  SPECIAL PROCEDURE PACK\tDYNJ88258  \t  VASCULAR ACCESS PACK-LF\tDYNJ0101291G  \t  VASCULAR HYBRID\tDYNJ57543K  \t  VASCULAR PACK\tDYNJ82220D  \t  VISCERAL ANGIOGRAM PACK-LF\tDYNJ0429121M  \t  WPH EP PACK\tDYNJ62745A — reason: Unapproved design changes to the products outside of the 510(k) clearance.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-27. Affected lots/codes: DYNJ0429339L  UDI-DI 10195327586508 (EA) 40195327586509 (CS) LOTS 24BMG223    24DMG627     DYNJ0429339M  UDI-DI 10198459021541 (EA) 40198459021542 (CS) LOTS  24GMH043    24HMK218     DYNJ0774026K  UDI-DI 10198459053115 (EA) 40198459053116 (CS) LOTS  24FBR752    24GBE275    24HBJ727    24IBD206    24KBB390    24KBT291     DYNJ83746B  UDI-DI 10198459077760 (EA) 40198459077761 (CS) LOTS  24HBB576    24JBF419    24LBG659     DYNJ85557A  UDI-DI 10195327657901 (EA) 40195327657902 (CS) LOT  24HBT042     DYNJ17218S  UDI-DI 10195327617547 (EA) 40195327617548 (CS) LOTS 24ADC205    24DDA061     DYNJ17218T  UDI-DI 10198459014956 (EA) 40198459014957 (CS) LOTS  24FDA217    24GDB466    24IDB458     DYNJ0842499L  UDI-DI 10198459119248 (EA) 40198459119249 (CS) LOT  24LDB079     DYNJ0842478M  UDI-DI 10198459119255 (EA) 40198459119256 (CS) LOT  24LDB078     DYNJ21259O  UDI-DI 10195327666323 (EA) 40195327666324 (CS) LOTS  24EBQ265    24EBQ331    24KBG416    24LBP987     DYNJ68653D  UDI-DI 10198459123122 (EA) 40198459123123 (CS) LOTS  24IBI799    24JBJ553    24KBT807    24LBQ652     DYNJ50779G  UDI-DI 10195327686499 (EA) 40195327686490 (CS) LOTS  24GMA788    24HMA312    24IMI472    24KMC197     DYNJ51423G  UDI-DI 10198459022395 (EA) 40198459022396 (CS) LOTS  24FLA167    24HLA548    24HLA720    24JLA538     DYNJ0101292I  UDI-DI 10198459119064 (EA) 40198459119065 (CS) LOTS  24JDA749    24KDB872    24LDA883     DYNJ0842793I  UDI-DI 10198459119095 (EA) 40198459119096 (CS) LOTS  24IDA565    24JDB658     DYNJ87263  UDI-DI 10198459026263 (EA) 40198459026264 (CS) LOTS  24GMF532    24KME090     DYNJ0842873L  UDI-DI 10198459119163 (EA) 40198459119164 (CS) LOTS  24JDB216    24KMI624     DYNJ45984J  UDI-DI 10198459072499 (EA) 40198459072490 (CS) LOTS  24HMD351    24IMJ054     DYNJ87218  UDI-DI 10198459018800 (EA) 40198459018801 (CS) LOTS  24GBA517    24IBO012    24LBT366     DYNJ82191D  UDI-DI 10198459099755 (EA) 40198459099756 (CS) LOTS  24HMI555    24IMF587    24KMD232     DYNJ61373B  UDI-DI 10195327591298 (EA) 40195327591299 (CS) LOTS  23LBS736    24ABA334    24KBF375    24LBM612     DYNJ0843063M UDI-DI 10198459119460 (EA) 40198459119461 (CS) LOTS  24LDB299     DYNJ0101287M  UDI-DI 10198459119491 (EA) 40198459119492 (CS) LOTS  24JDA631    24KDB258     DYNJ68365F  UDI-DI 10198459130038 (EA) 40198459130039 (CS) LOTS 24LBA409    24LBJ115    24LBJ634     DYNJ0843121L  UDI-DI 10198459119507 (EA) 40198459119508 (CS) LOTS  24JMB397    24JMF145     DYNJ56386C  UDI-DI 10195327571252 (EA) 40195327571253 (CS) LOTS  23LBI856    24CBJ902    24FBG624    24FBI743    24FBO911    24HBM314     DYNJ56386D  UDI-DI 10198459123382 (EA) 40198459123383 (CS) LOTS  24JBX744    24KBH891    24LBS655     DYNJ83656A  UDI-DI 10195327600006 (EA) 40195327600007 (CS) LOTS  24DMF381    24GMG344     DYNJ83656B  UDI-DI 10198459119538 (EA) 40198459119539 (CS) LOT  24KMF093     DYNJ62747A  UDI-DI 10195327576530 (EA) 40195327576531 (CS) LOTS 24EBI547    24FBR560    24IBG783    24LBK728     DYNJ30551J  UDI-DI 10198459131004 (EA) 40198459131005 (CS) LOTS  24LLA323    25HLA222     DYNJ61383C  UDI-DI 10195327593346 (EA) 40195327593347 (CS) LOTS  24CLA801    24DLA314    24ELA254    24FLA499    24GLA460    24HLA582    24HLB160    24JLB130    24KLB068    24LLA374    25ALA225    25ALB027    25CLA749    25DLA276    25GLA032    25ILA468    25JLA750     DYNJ0774005I  UDI-DI 10198459053184 (EA) 40198459053185 (CS) LOTS  24GBE276    24HBS310     DYNJ30554I  UDI-DI 10198459131011 (EA) 40198459131012 (CS) LOTS  24LLB049    25HLA223    25HLA971     DYNJ46333G  UDI-DI 10195327542320 (EA) 40195327542321 (CS) LOT  24ABS351     DYNJ0843339P  UDI-DI 10198459119330 (EA) 40198459119331 (CS) LOTS  24JDC273    24LDA042     DYNJ36338D  UDI-DI 10195327624002 (EA) 40195327624003 (CS) LOTS  24BMJ645    24CMG670    24DMC608    24EMH999    24FME392    24JMD753    24JMI596    24KME048    24LMA450     DYNJ88258  UDI-DI 10198459133114 (EA) 40198459133115 (CS) LOT  24JBB074     DYNJ0101291G  UDI-DI 10198459119439 (EA) 40198459119430 (CS) LOTS  24IDB422    24KDB372     DYNJ57543K  UDI-DI 10198459004124 (EA) 40198459004125 (CS) LOTS  24FMI037    24GMF547    24IMA891    24JME621     DYNJ82220D  UDI-DI 10198459103377 (EA) 40198459103378 (CS) LOT  24LMC859     DYNJ0429121M  UDI-DI 10195327675813 (EA) 40195327675814 (CS) LOTS  24DMA039    24DMG180    24EMH743    24IMF503     DYNJ62745A  UDI-DI 10195327686222 (EA) 40195327686223 (CS) LOTS  24KBR735    24LBK675  ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.***  DYNJ0101287M lots 25BMC014;  DYNJ0429121M lots 24GME309 25AMA768 25AMI616 25CMC127 25DME972 25EMH823;  DYNJ0429339M lots 25AMI338 25BMI962 25DMG132;  DYNJ0774005I lots 25ABU445 25EBJ726;  DYNJ0774026K lots 25ABL910 25CBC859;  DYNJ0842478M lots 25BMD033;  DYNJ0842499L lots 25ADA394 25ADB067 25BDB213;  DYNJ0842873L lots 25AMF044 25BMI157 25CMJ723;  DYNJ0843063M lots 24KDA944 25BMC710 25CMB746;  DYNJ0843121L lots 25BMA139 25BMG893;  DYNJ0843339P lots 25AMC387 25BMI894;  DYNJ30551J lots 25BLA948 25DLA390 25ELA675 25FLA636;  DYNJ30554I lots 25BLB061 25CLA785 25FLA348;  DYNJ36338D lots 25AMD997 25DMB069 25EMA091;  DYNJ50779G lots 25BMC031 25BMF563 25CMI786 25DMH709;  DYNJ51423G lots 25DLB019;  DYNJ56386D lots 25BBK025 25DBL564;  DYNJ57543K lots 25BMA534 25BMH775 25DMA332;  DYNJ61373B lots 25BBD697 25CBH388 25EBE177;  DYNJ62745A lots 24EBG787 24FBM384 24GBE754 24GBY096 24HBM688;  DYNJ62747A lots 24LBU340 25ABC752 25CBD229 25DBH729;  DYNJ68365F lots 25ABS737 25DBF630;  DYNJ68653D lots 25BBB109 25EBI916;  DYNJ82191D lots 25AMD097;  DYNJ82220D lots 25AMG555 25BMG434;  DYNJ83656A lots 24BMC933 24CMA913;  DYNJ83656B lots 25AMB305 25BMH455;  DYNJ87218 lots 25ABJ285 25BBK929. 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-1890-2026&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-1890-2026&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-1890-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1890-2026 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.",
      "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-1890-2026&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-1890-2026&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-1890-2026/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
      },
      "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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      "name": "FDA recall details — Z-1890-2026",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1890-2026",
            "Status": "recorded"
          }
        },
        {
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medline Industries, LP",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Unapproved design changes to the products outside of the 510(k) clearance.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-02-27",
            "Status": "recorded"
          }
        },
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}