{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Northfield", "state": "IL", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "98601", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "address_2": "N/A", "postal_code": "60093-2753", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.", "recall_number": "Z-1890-2026", "product_description": "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", "product_quantity": "270,311 total", "reason_for_recall": "Unapproved design changes to the products outside of the 510(k) clearance.", "recall_initiation_date": "20260227", "center_classification_date": "20260417", "report_date": "20260429", "code_info": "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", "more_code_info": "" } ] }