{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1883-2026.jsonld", "@type": "schema:Dataset", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF\tDYNJ87052 BASIC PACK\tDYNJ83976 \t BASIC SET UP PACK\tDYNJ80700 \t CORONARY ANGIOGRAPHY PACK (N)\tDYNJ42136B \t CSTM ANGIO KIT - S VASC1109 \t CV PACK\tDYNJ46301C \t DR F PACK\tDYNJ41253B \t ENSEMBLE HEMORROIDES\tDYNJ56311A \t G TAVR PACK\tDYNJ61006 \t IR MINOR PACK\tDYNJ44139C \t MAJOR PLUS PACK\tDYNJ905160N \t MAXIMUM BARRIER BUNDLE PACK\tDYNJ35216C \t PCI PACK TBRHSC-LF\tDYNJ41941D \t PERC PACK-LF\tDYNJ0774759P \t PERIPHERAL ANGIOGRAPHY PK\tDYNJ42094B \t PROCEDURE PACK\tDYNJ55063B \t PTCA PACK\tDYNJ55359B \t ROBOTIC PACK\tDYNJ908706C \t SPECIAL PROCEDURES TRAY\tDYNJ41174A \t SYRINGE WIRE KIT SANFORD\tSAMPC0644 \t WPH EP PACK\tDYNJ62745 \t X-RAY PACK\tDYNJ44295G", "description": "FDA recall Z-1883-2026 — Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF\tDYNJ87052 BASIC PACK\tDYNJ83976 \t BASIC SET UP PACK\tDYNJ80700 \t CORONARY ANGIOGRAPHY PACK (N)\tDYNJ42136B \t CSTM ANGIO KIT - S VASC1109 \t CV PACK\tDYNJ46301C \t DR F PACK\tDYNJ41253B \t ENSEMBLE HEMORROIDES\tDYNJ56311A \t G TAVR PACK\tDYNJ61006 \t IR MINOR PACK\tDYNJ44139C \t MAJOR PLUS PACK\tDYNJ905160N \t MAXIMUM BARRIER BUNDLE PACK\tDYNJ35216C \t PCI PACK TBRHSC-LF\tDYNJ41941D \t PERC PACK-LF\tDYNJ0774759P \t PERIPHERAL ANGIOGRAPHY PK\tDYNJ42094B \t PROCEDURE PACK\tDYNJ55063B \t PTCA PACK\tDYNJ55359B \t ROBOTIC PACK\tDYNJ908706C \t SPECIAL PROCEDURES TRAY\tDYNJ41174A \t SYRINGE WIRE KIT SANFORD\tSAMPC0644 \t WPH EP PACK\tDYNJ62745 \t X-RAY PACK\tDYNJ44295G (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-1883-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF\tDYNJ87052 BASIC PACK\tDYNJ83976 \t BASIC SET UP PACK\tDYNJ80700 \t CORONARY ANGIOGRAPHY PACK (N)\tDYNJ42136B \t CSTM ANGIO KIT - S VASC1109 \t CV PACK\tDYNJ46301C \t DR F PACK\tDYNJ41253B \t ENSEMBLE HEMORROIDES\tDYNJ56311A \t G TAVR PACK\tDYNJ61006 \t IR MINOR PACK\tDYNJ44139C \t MAJOR PLUS PACK\tDYNJ905160N \t MAXIMUM BARRIER BUNDLE PACK\tDYNJ35216C \t PCI PACK TBRHSC-LF\tDYNJ41941D \t PERC PACK-LF\tDYNJ0774759P \t PERIPHERAL ANGIOGRAPHY PK\tDYNJ42094B \t PROCEDURE PACK\tDYNJ55063B \t PTCA PACK\tDYNJ55359B \t ROBOTIC PACK\tDYNJ908706C \t SPECIAL PROCEDURES TRAY\tDYNJ41174A \t SYRINGE WIRE KIT SANFORD\tSAMPC0644 \t WPH EP PACK\tDYNJ62745 \t X-RAY PACK\tDYNJ44295G", "manufacturer": { "@type": "schema:Organization", "name": "Medline Industries, LP" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1883-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1883-2026: Medline Industries, LP is recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF\tDYNJ87052 BASIC PACK\tDYNJ83976 \t BASIC SET UP PACK\tDYNJ80700 \t CORONARY ANGIOGRAPHY PACK (N)\tDYNJ42136B \t CSTM ANGIO KIT - S VASC1109 \t CV PACK\tDYNJ46301C \t DR F PACK\tDYNJ41253B \t ENSEMBLE HEMORROIDES\tDYNJ56311A \t G TAVR PACK\tDYNJ61006 \t IR MINOR PACK\tDYNJ44139C \t MAJOR PLUS PACK\tDYNJ905160N \t MAXIMUM BARRIER BUNDLE PACK\tDYNJ35216C \t PCI PACK TBRHSC-LF\tDYNJ41941D \t PERC PACK-LF\tDYNJ0774759P \t PERIPHERAL ANGIOGRAPHY PK\tDYNJ42094B \t PROCEDURE PACK\tDYNJ55063B \t PTCA PACK\tDYNJ55359B \t ROBOTIC PACK\tDYNJ908706C \t SPECIAL PROCEDURES TRAY\tDYNJ41174A \t SYRINGE WIRE KIT SANFORD\tSAMPC0644 \t WPH EP PACK\tDYNJ62745 \t X-RAY PACK\tDYNJ44295G", "text": "The FDA logged enforcement record Z-1883-2026: Medline Industries, LP is voluntarily recalling Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BASIC CL PACK-LF\tDYNJ87052 BASIC PACK\tDYNJ83976 \t BASIC SET UP PACK\tDYNJ80700 \t CORONARY ANGIOGRAPHY PACK (N)\tDYNJ42136B \t CSTM ANGIO KIT - S VASC1109 \t CV PACK\tDYNJ46301C \t DR F PACK\tDYNJ41253B \t ENSEMBLE HEMORROIDES\tDYNJ56311A \t G TAVR PACK\tDYNJ61006 \t IR MINOR PACK\tDYNJ44139C \t MAJOR PLUS PACK\tDYNJ905160N \t MAXIMUM BARRIER BUNDLE PACK\tDYNJ35216C \t PCI PACK TBRHSC-LF\tDYNJ41941D \t PERC PACK-LF\tDYNJ0774759P \t PERIPHERAL ANGIOGRAPHY PK\tDYNJ42094B \t PROCEDURE PACK\tDYNJ55063B \t PTCA PACK\tDYNJ55359B \t ROBOTIC PACK\tDYNJ908706C \t SPECIAL PROCEDURES TRAY\tDYNJ41174A \t SYRINGE WIRE KIT SANFORD\tSAMPC0644 \t WPH EP PACK\tDYNJ62745 \t X-RAY PACK\tDYNJ44295G — 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: DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; DYNJ41941D lots 24LBU189 25EBO278; DYNJ42094B lots 21DDA142 21EDA157 21FDA721 21HDC553 21JDB308 21KDC411 22ADB304 22DDA696 22EDB388 22GDB457 22HDC130 22KDB833 23ADA446 23BDB104 23DDA367 23EDA799 23FDB379 23HDB674 23KDA291 23KDC457 24ADA586 25DMB689 25EMH157; DYNJ42136B lots 20XBH732 21FBD068 21FBP137 21GBM895 21IBO938 21JBW334 21LBK626 22DBB070 22DBT749 22DBT751 22GBL802 22KMB909 23AMA925 23AMA926 23DMC128 23EMK206 23FMD274 23GMI199 23IMF729 23KMG485 25DMG003 25EMJ002; DYNJ44139C lots 21ABF720 21BBP639 21OBA387 DYNJ46301C 23EMD296; DYNJ55359B lots 21CBY049 21HBJ347 21KBK603 21LBU329 22BBN805 22DBG945 22DBG946 22EBI619 22EBI620 22GBV248 22IBD917 22JBP712 22KBO285 22LBF294 23BBN404 23CBU106; DYNJ61006 lots 21BBM590 21DBE579 25EBA174; DYNJ62745 lots 21CBZ899 21EBI827 21HBB755 21KBR329 21LBP817 22BBB761 22BBY454 22FBG531 22FBG532 22GBH888 22HBH100 22JBS334 23ABF660 23BBR901 23DBC087 23EBN460 23FBQ453 23GBH068 23IBB014 23JBP276 23LBJ141 24BBR785 24BBS830; VASC1109 lots 25BBR047. 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-1883-2026&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-1883-2026&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-1883-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1883-2026 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-1883-2026&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-1883-2026&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-1883-2026/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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1883-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1883-2026", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "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" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "DYNJ87052 UDI-DI 10198459005121 (EA) 40198459005122 (CS) LOTS 24FLA345 24FLA915 24HLB029 DYNJ83976 UDI-DI 10195327323196 (EA) 40195327323197 (CS) LOTS 24ABO128 DYNJ80700 UDI-DI 10195327066925 (EA) 40195327066926 (CS) LOTS 24BBD119 DYNJ42136B UDI-DI 10889942825288 (EA) 40889942825289 (CS) LOTS 23EMC679 24BMC063 24BMF939 24DMH398 24FMB963 24GMH870 24HMI957 24JMB273 24KMI914 VASC1109 UDI-DI 10889942779079 (EA) 40889942779070 (CS) LOTS 20EBW196 20FBR136 20HBV757 20JBC396 21ABE357 21ABT166 21BBN949 21CBS148 21EBB385 21KBD389 21LBD078 22BBV291 22DBN021 22EBO307 22GBZ351 22JBD956 23FBJ696 23HBR604 23IBF895 24JBK913 24KBR194 DYNJ46301C UDI-DI 10193489527889 (EA) 40193489527880 (CS) LOT 23LMH904 DYNJ41253B UDI-DI 10888277958173 (EA) 40888277958174 (CS) LOT 24ABP897 DYNJ56311A UDI-DI 10193489360127 (EA) 40193489360128 (CS) LOT 24ABR871 DYNJ61006 UDI-DI 10193489546194 (EA) 40193489546195 (CS) LOTS 21FBT962 21HBE414 21JBK356 21LBU392 22HBH070 22IBD976 22OBF481 23ABS489 23BBT198 23EBR237 23GBH211 23IBP468 23JBC690 23KBJ782 23LBT261 24BBQ276 24DBG218 24EBQ703 24GBE940 24IBD970 24JBA173 24KBQ943 DYNJ44139C UDI-DI 10193489226102 (EA) 40193489226103 (CS) LOTS 21EBS091 21GBI562 21HBR793 21IBX717 21KBJ549 22ABH554 22BBM456 22DBS762 22FBJ076 22FBR590 22IBB384 22KBF481 22LBB630 22OBG108 23ABJ826 23BBO865 23CBR417 23DBN752 23EBV786 23GBR439 23IBE449 23IBU640 23KBJ599 23LBP229 24ABC062 24EMG282 24IMC574 DYNJ905160N UDI-DI 10195327664473 (EA) 40195327664474 (CS) LOTS 24DMC432 24EMG685 DYNJ35216C UDI-DI 10889942952618 (EA) 40889942952619 (CS) LOTS 22GDA210 24IDA943 24KDA980 24LDA479 DYNJ41941D UDI-DI 10193489753707 (EA) 40193489753708 (CS) LOTS 20ABB748 20ABV122 20BBA524 20CBN068 20EBG674 20FBD191 20HBS587 20JBT996 21ABI859 21ABJ490 21BBD481 21CBH747 21DBH332 21JBE257 21JBU827 21LBR129 22CBZ848 22FBK880 22IBT430 22KBT522 22OBG445 23BBB312 23CBR316 23DBO494 23GBQ439 23HBM965 23HBX738 23IBU090 23JBV457 23LBF066 23LBT768 24CBG494 24DBG816 24EBC719 24JBF955 24KBD843 DYNJ0774759P UDI-DI 10195327246136 (EA) 40195327246137 (CS) LOT 24DMH153 DYNJ42094B UDI-DI 10889942820849 (EA) 40889942820840 (CS) LOTS 24CDA087 24EDA493 24HDA294 24IDA278 24IDB151 24IME505 24JMF227 24KMC897 24LME897 DYNJ55063B UDI-DI 10195327538972 (EA) 40195327538973 (CS) LOT 24ABP065 DYNJ55359B UDI-DI 10193489235517 (EA) 40193489235518 (CS) LOTS 23DBI651 23FBR555 23GBK876 23HBC455 23IBC298 23KBN808 24BBO002 24DBG256 24DBQ490 24EBJ876 24GBO458 DYNJ908706C UDI-DI 10195327664497 (EA) 40195327664498 (CS) LOT 24EMG687 DYNJ41174A UDI-DI 10195327366254 (EA) 40195327366255 (CS) LOT 23JBK389 SAMPC0644 UDI-DI 10193489356885 (EA) 40193489356886 (CS) LOT 20FDA159 DYNJ62745 UDI-DI 10193489688160 (EA) 40193489688161 (CS) LOT 24ABQ796 DYNJ44295G UDI-DI 10195327431273 (EA) 40195327431274 (CS) LOT 24IBH033 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ35216C lots 21BDA005 21CDA164 21DDB532 21IDA938 21KDB822 22ADB494 22ADC166 22CDB658 22DDC504 22HDA355 22LDA336 23BDB027 23BDC034 23DDA002 23DDA917 23GDA443 23HDA139 23JDC163 23LDA319 24DDA760 24GDA206 24GDB408 25BDA073 25DDA617 25DDB847; 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