{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216741", "product_res_number": "Z-0526-2026", "event_date_initiated": "2025-09-30", "event_date_posted": "2025-11-14", "recall_status": "Open, Classified", "res_event_number": "97846", "product_code": "OHM", "product_description": "MEDLINE convenience kits labeled as: \n1) C-SECTION OR 30 CDS, REF CDS820075W; \n2) C-SECTION, REF CDS984261J; \n3) C-SECTION CDS, REF CDS985282F; \n4) C-SECTION PACK, REF DYNJ02577D; \n5) C-SECTION PACK-LF, REF DYNJ0536924U; \n6) C-SECTION PACK-LF, REF DYNJ0551169V; \n7) C-SECTION PACK-LF, REF DYNJ0551409P; \n8) C-SECTION PACK-LF, REF DYNJ07836R; \n9) C-SECTION, REF DYNJ14103C; \n10) C-SECTION PACK, REF DYNJ19417R; \n11) C-SECTION PACK-LF, REF DYNJ33059B; \n12) C-SECTION PACK SC-LF, REF DYNJ38063D; \n13) C-SECTION PACK SC-LF, REF DYNJ38700G; \n14) C-SECTION PACK-LF, REF DYNJ38845D; \n15) C-SECTION PACK-LF, REF DYNJ38845F; \n16) C-SECTION PACK, REF DYNJ44679L; \n17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; \n18) C SECTION PACK, REF DYNJ48087I; \n19) C-SECTION I, REF DYNJ51354B; \n20) C-SECTION SAFETY PACK, REF DYNJ52481B; \n21) C-SECTION SMMC, REF DYNJ59457B; \n22) C-SECTION PACK, REF DYNJ59825A; \n23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; \n24) C SECTION PACK, REF DYNJ64377D; \n25) C-SECTION PACK, REF DYNJ64505B; \n26) C SECTION SHARED, REF DYNJ64775C; \n27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; \n28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; \n29) C-SECTION PACK-LF, REF DYNJ65031D; \n30) C SECTION PK, REF DYNJ65403A; \n31) C SECTION PACK-LF, REF DYNJ65765A; \n32) C-SECTION PACK-LF, REF DYNJ69445; \n33) C-SECTION PACK-LF, REF DYNJ69445A; \n34) C SECTION DELIVERY PACK, REF DYNJ81604A; \n35) C SECTION DELIVERY PACK, REF DYNJ81604B; \n36) C SECTION PACK, REF DYNJ82949; \n37) C-SECTION ADD ON PACK, REF DYNJ83507; \n38) C-SECTION PACK, REF DYNJ83980; \n39) C SECTION ACCESS, REF DYNJ85612; \n40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; \n41) C-SECTION PACK, REF DYNJ86173; \n42) C-SECTION, REF DYNJ900266F; \n43) C-SECTION, REF DYNJ903865D; \n44) C-SECTION, REF DYNJ904612G; \n45) C-SECTION, REF DYNJ904612I; \n46) C-SECTION, REF DYNJ904653G; \n47) C-SECTION, REF DYNJ904697F; \n48) CDS C-SECTION CH, REF DYNJ906263D; \n49) C SECTION, REF DYNJ908327; \n50) C-SECTION -LF, REF DYNJ9932207R; \n51) C-SECTION -LF, REF DYNJ9932207S; \n52) C-SECTION PACK, REF DYNJV0322A; \n53) GP-C SECTION PACK-LF, REF PHS396980007C.", "code_info": "REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; \nREF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; \nREF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; \nREF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; \nREF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; \nREF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; \nREF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; \nREF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; \nREF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; \nREF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; \nREF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; \nREF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; \nREF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; \nREF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; \nREF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; \nREF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; \nREF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24BBV536; \nREF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24EBF239; \nREF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23HMD981; \nREF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23KBF163; \nREF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBH765; \nREF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBT798; \nREF DYNJ0551409P, UDI/DI: 10195327561871 (each) 40195327561872 (case), Lot Numbers: 24BBC833; \nREF DYNJ07836R, UDI/DI: 10195327349431 (each) 40195327349432 (case), Lot Numbers: 24BBH764; \nREF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 23LBC980; \nREF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABQ944; \nREF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABR003; \nREF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABV987; \nREF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24BBG949; \nREF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23GMF903; \nREF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23HMF589; \nREF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23JMB497; \nREF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23EBO244; \nREF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23FBR011; \nREF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBD673; \nREF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBH801; \nREF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23IBP528; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMF816; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMI790; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23EMG135; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23FMI968; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23GMI116; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23HMA195; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23JMC837; \nREF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 24BMB829; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23DMI785; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23EMJ326; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23GMD537; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23IMF534; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23KMB242; \nREF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 24BMC270; \nREF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23HBQ392; \nREF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23LBT819; \nREF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24CBM675; \nREF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24EBP120; \nREF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBK092; \nREF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBS759; \nREF DYNJ47808F, UDI/DI: 10195327232603 (each) 40195327232604 (case), Lot Numbers: 23GMI543; \nREF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24ABE884; \nREF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24BBI603; \nREF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24CBU107; \nREF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23JME469; \nREF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23KMH696; \nREF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24DMD663; \nREF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24KMD766; \nREF DYNJ52481B, UDI/DI: 10195327689773 (each) 40195327689774 (case), Lot Numbers: 24DBO831; \nREF DYNJ59457B, UDI/DI: 10195327446574 (each) 40195327446575 (case), Lot Numbers: 23KMD078; \nREF DYNJ59825A, UDI/DI: 10195327331610 (each) 40195327331611 (case), Lot Numbers: 23HLA627; \nREF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBD197; \nREF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBR612; \nREF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23EBB409; \nREF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23GBG734; \nREF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23HBM866; \nREF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23IBR809; \nREF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 23HBI631; \nREF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24ABI243; \nREF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24BBC533; \nREF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24DBO874; \nREF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23EDC402; \nREF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23FDC227; \nREF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23HDB277; \nREF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23IMG148; \nREF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23JME325; \nREF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23LMA555; \nREF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24AMF996; \nREF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24BMI121; \nREF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24CMF007; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23KMI521; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23LMF119; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24AMC075; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24CMI550; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24EMH988; \nREF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24FME482; \nREF DYNJ65403A, UDI/DI: 10193489417081 (each) 40193489417082 (case), Lot Numbers: 24ABS258; \nREF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23EBO612; \nREF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23HBR353; \nREF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23IBJ604; \nREF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23KBD084; \nREF DYNJ69445, UDI/DI: 10193489942514 (each) 40193489942515 (case), Lot Numbers: 23GBA532; \nREF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 23KBU661; \nREF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBH876; \nREF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBI439; \nREF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23DBJ057; \nREF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23EBN921; \nREF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23FBB765; \nREF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23GBK114; \nREF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23JBK156; \nREF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23EBM401; \nREF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23IBQ454; \nREF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23HBW089; \nREF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23IBK153; \nREF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBU485; \nREF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBV117; \nREF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 24DBR994; \nREF DYNJ83980, UDI/DI: 10195327323554 (each) 40195327323555 (case), Lot Numbers: 24ABR096; \nREF DYNJ85612, UDI/DI: 10195327523770 (each) 40195327523771 (case), Lot Numbers: 23LMF612; \nREF DYNJ85770, UDI/DI: 10195327546557 (each) 40195327546558 (case), Lot Numbers: 24AMG054; \nREF DYNJ86173, UDI/DI: 10195327609412 (each) 40195327609413 (case), Lot Numbers: 24CBA422; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBG515; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBQ424; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABG727; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABS178; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABW963; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24BBQ451; \nREF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24CBT653; \nREF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23KMD690; \nREF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23LMG846; \nREF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 24AMG510; \nREF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 23LMC684; \nREF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 24AMA761; \nREF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24CMH459; \nREF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24GMH592; \nREF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23HBH779; \nREF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23IBP238; \nREF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23JBS995; \nREF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23KBM075; \nREF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23EDB517; \nREF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23FDB192; \nREF DYNJ906263D, UDI/DI: 10195327344375 (each) 40195327344376 (case), Lot Numbers: 23HBJ335; \nREF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23HMD044; \nREF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23JMH952; \nREF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23KMF087; \nREF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 24AMB283; \nREF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23GMI390; \nREF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23KMJ296; \nREF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23LMH787; \nREF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 24BMJ492; \nREF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24DMG311; \nREF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24FMB530; \nREF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24HMJ414; \nREF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23JMF237; \nREF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23KMG863; \nREF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24AMI231; \nREF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24HMD222; \nREF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23GDB702; \nREF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23HDA942.", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-369-1704", "reason_for_recall": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.", "root_cause_description": "Under Investigation by firm", "action": "Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions: \n1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.\n2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form. \n3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\n4. For distributors or those who have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "11032 kits", "distribution_pattern": "US Nationwide distribution.", "openfda": { "registration_number": [ "3014325891", "2433012", "1018470", "3004111573", "3045816907", "3015173212", "1423395", "3035642068", "1043214", "1047429", "1928237", "3004122598", "3026197444", "1643817", "3018071447", "9616088", "3045816902", "2029015", "3004362278", "3004911384", "1054241", "3007329020", "3009203853", "3008513424", "1055236", "3005012805", "3009888344", "1423537", "3005595283", "1061124", "1030451" ], "fei_number": [ "3014325891", "2433012", "1018470", "3004111573", "3045816907", "1000160458", "3000717925", "3002902735", "3015173212", "3035642068", "1043214", "1047429", "1928237", "1000112968", "3004122598", "3026197444", "1643817", "3018071447", "3045816902", "1000512168", "3004362278", "3004911384", "3007329020", "3001236905", "3009203853", "3008513424", "3005012805", "3009888344", "3005595283", "1030451", "1000112877" ], "device_name": "Cesarean Section Tray", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.1720", "device_class": "2" } } ] }