Class 2 Device Recall Medline

• Date Initiated by Firm: October 09, 2024
• Date Posted: December 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0645-2025
• Recall Event ID: 95621
• Product Classification: Cesarean section tray - Product Code OHM
• Product: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP
• Code Information: 85OHM 1) REF CDS820075V, UDI/DI 10193489846973 (each) 40193489846974 (case), Lot Numbers: 22GBP851; 2) REF CDS820075W, UDI/DI 10195327209797 (each) 40195327209798 (case), Lot Numbers: 22HBH009, 23ABB066, 22JBX603, 22JBX483, 23ABM869, 22LBB096, 23EBB528, 23FBH057; 3) REF CDS980774M, UDI/DI 10193489383713 (each) 40193489383714 (case), Lot Numbers: 22JBT027, 23ABE914, 22KBE813, 23ABR052, 23GBL705, 24ABK006, 23JBQ162, 23LBT739, 23LBT825; 4) REF CDS981322AB, UDI/DI 10193489929997 (each) 40193489929998 (case), Lot Numbers: 22DBS923, 23EBE751, 23BBE438, 23HBS136; 5) REF CDS981322AC, UDI/DI 10195327539481 (each) 40195327539482 (case), Lot Numbers: 23LBJ448, 23LBJ388, 24BBF433, 24DMH817; 6) REF CDS982398I, UDI/DI 10195327029449 (each) 40195327029440 (case), Lot Numbers: 22HBF545, 22IBC664, 22JBL415, 22LBH995, 23BBS835, 23LBA643, 23JBV944, 23IBE632, 23HBJ717, 23EBP485, 24ABO332, 23FBS672, 24BBK936, 24EBC031, 24DBD943, 24CBU322, 24GBD705; 7) REF CDS983450L, UDI/DI 10193489372335 (each) 40193489372336 (case), Lot Numbers: 23ABF826, 23BBG537, 22FBS278, 22KBE444, 23JBR792; 8) REF CDS983869J, UDI/DI 10195327457617 (each) 40195327457618 (case), Lot Numbers: 23HDA541; 9) REF CDS984261J, UDI/DI 10195327139629 (each) 40195327139620 (case), Lot Numbers: 22IBF149, 23EBG169, 23CBE760, 22LBJ360, 22KBS546, 22KBS547; 10) REF CDS984516L, UDI/DI 10195327338626 (each) 40195327338627 (case), Lot Numbers: 23FDA887, 23HDB446, 23LDA038, 23JDB032, 23IDB803, 24ADA525, 23LDB093; 11) REF CDS984516M, UDI/DI 10195327629847 (each) 40195327629848 (case), Lot Numbers: 24BDB731, 24BDA997; 12) REF CDS984902K, UDI/DI 10195327156923 (each) 40195327156924 (case), Lot Numbers: 22LBH577, 23KBB878, 23HBU537, 23ABM570, 24ABI595, 24ABD063; 13) REF CDS984902L, UDI/DI 10195327584955 (each) 40195327584956 (case), Lot Numbers: 24DBI303; 14) REF CDS985282F, UDI/DI 10193489645606 (each) 40193489645607 (case), Lot Numbers: 22GBE278, 22FBL413, 22JBU598, 23DBL267, 23CBR985, 23BBN513, 23BBN776, 22KBR845, 23FBD738; 15) REF CDS985326G, UDI/DI 10195327091170 (each) 40195327091171 (case), Lot Numbers: 22GBJ024, 22GBF342, 22GBT686, 22FBR937, 23DBB697, 23ABJ487, 23JBU241; 16) REF CDS985505G, UDI/DI 10195327412555 (each) 40195327412556 (case), Lot Numbers: 23HBK247, 23GBD611, 23JBN811, 23JBN997; 17) REF CDSCCR611Q, UDI/DI 10195327398668 (each) 40195327398669 (case), Lot Numbers: 23GBU646, 23IBG367, 23KBJ756, 23JBS637; 18) REF DYNJ0100978K, UDI/DI 10195327339005 (each) 40195327339006 (case), Lot Numbers: 23GDB484, 23DDA636; 19) REF DYNJ0101147G, UDI/DI 10195327059880 (each) 40195327059881 (case), Lot Numbers: 22JMF390, 22LMD489, 23BMA081, 23GMI901, 23HMH876, 23JMI277, 23JMH328; 20) REF DYNJ0101562I, UDI/DI 10193489961935 (each) 40193489961936 (case), Lot Numbers: 22GDA866, 22FDA774; 21) REF DYNJ0101562K, UDI/DI 10195327351120 (each) 40195327351121 (case), Lot Numbers: 23GDB485; 22) REF DYNJ0101616L, UDI/DI 10195327339357 (each) 40195327339358 (case), Lot Numbers: 23CDA045, 23HDB479; 23) REF DYNJ0173422AF, UDI/DI 10195327097578 (each) 40195327097579 (case), Lot Numbers: 22GMA837, 22EMD852; 24) REF DYNJ0173422AG, UDI/DI 10195327308872 (each) 40195327308873 (case), Lot Numbers: 23GMD128, 23CME302, 23BMC001, 23KMD310, 23JMG171, 23IMH940; 25) REF DYNJ0190625Q, UDI/DI 10193489442595 (each) 40193489442596 (case), Lot Numbers: 22HME285, 22EMH998, 22KMF633, 22GMA165, 23EMG450, 23HMD259, 24BMC716, 23JMF345, 23JMA122, 23GMC332, 23FMA882, 23AMF892, 23AMH766, 23EMD161, 24AMI109, 24CMG231; 26) REF DYNJ02577D, UDI/DI 10193489958003 (each) 40193489958004 (case), Lot Numbers: 22HDB948, 22EDB860, 23BDB332, 22KDB125; 27) REF DYNJ02748F, UDI/DI 10193489990515 (each) 40193489990516 (case), Lot Numbers: 22IBQ419, 22CBA218, 22EBT508, 22DBB815, 22LBT229; 28) REF DYNJ0282506N, UDI/DI 10195327376031 (each) 40195327376032 (case), Lot Numbers: 23HBA336, 23EBO853, 23FBQ455, 23IBM182, 23GBN258; 29) REF DYNJ0366291O, UDI/DI 10195327484606 (each) 40195327484607 (case), Lot Numbers: 23JMG161, 23KME060; 30) REF DYNJ0378325M, UDI/DI 10195327304805 (each) 40195327304806 (case), Lot Numbers: 23BBC501, 23FBB034, 23BBQ557, 23GBH191; 31) REF DYNJ0378325N, UDI/DI 10195327513009 (each) 40195327513000 (case), Lot Numbers: 23JBB974; 32) REF DYNJ0451410O, UDI/DI 10195327056865 (each) 40195327056866 (case), Lot Numbers: 23CBS827, 22LBI914, 22LBI917, 22HBY191, 23GBI349, 23EBS204, 23IBJ885, 22EBK705, 22FBG444, 22GBY085; 33) REF DYNJ0536924T, UDI/DI 10193489780536 (each) 40193489780537 (case), Lot Numbers: 22EBG273; 34) REF DYNJ0536924U, UDI/DI 10195327206246 (each) 40195327206247 (case), Lot Numbers: 22IBK716, 22JBS240, 22LBO707, 23CBD070, 23DBM191, 23DBJ376; 35) REF DYNJ0551169V, UDI/DI 10889942826582 (each) 40889942826583 (case), Lot Numbers: 22HMG780, 22GMA047, 23CMH765; 36) REF DYNJ0551409O, UDI/DI 10889942796830 (each) 40889942796831 (case), Lot Numbers: 22CMF714, 22DMF407, 23BMA852, 23AMF749, 23DMG690; 37) REF DYNJ0619806K, UDI/DI 10195327102319 (each) 40195327102310 (case), Lot Numbers: 22FME410, 22EMF442; 38) REF DYNJ0619806O, UDI/DI 10195327333058 (each) 40195327333059 (case), Lot Numbers: 23JBX178, 23JBD575, 23IBV027; 39) REF DYNJ0778455D, UDI/DI 10193489457728 (each) 40193489457729 (case), Lot Numbers: 22GME460, 22DMF547, 22IMG788, 22LMG702, 22LMB815; 40) REF DYNJ0778455F, UDI/DI 10195327330521 (each) 40195327330522 (case), Lot Numbers: 23CMG761, 23CMA106, 23EMC025, 23HMH346; 41) REF DYNJ0778455G, UDI/DI 10195327509880 (each) 40195327509881 (case), Lot Numbers: 23JMB763, 23LMD395, 23KMB462, 24AMI890, 24BMC717, 24CMH746, 24BMJ539, 24DMD059; 42) REF DYNJ07836Q, UDI/DI 10195327209551 (each) 40195327209552 (case), Lot Numbers: 22IBO410; 43) REF DYNJ0842739L, UDI/DI 10195327286521 (each) 40195327286522 (case), Lot Numbers: 23DDB461, 23FDA248, 44) REF DYNJ0842739M, UDI/DI 10195327480325 (each) 40195327480326 (case), Lot Numbers: 23HDA724, 24ADA102; 45) REF DYNJ0854363I, UDI/DI 10193489484441 (each) 40193489484442 (case), Lot Numbers: 22EMG893, 22KMF923, 22IMB668, 22FMG438, 23IMD033, 23CMA343, 23FMF107; 46) REF DYNJ0854363J, UDI/DI 10195327534257 (each) 40195327534258 (case), Lot Numbers: 23KMB143, 24AMC963, 24BMG075; 47) REF DYNJ0868053S, UDI/DI 10195327268404 (each) 40195327268405 (case), Lot Numbers: 23KMI025, 23FMD356, 23KMI504; 48) REF DYNJ09174O, UDI/DI 10195327150228 (each) 40195327150229 (case), Lot Numbers: 22EMA263, 22LMF153, 23DMD390, 23JMH439; 49) REF DYNJ16026G, UDI/DI 10195327360603 (each) 40195327360604 (case), Lot Numbers: 23CBM555; 50) REF DYNJ16026I, UDI/DI 10195327542955 (each) 40195327542956 (case), Lot Numbers: 23LBH453; 51) REF DYNJ16614B, UDI/DI 10195327053710 (each) 40195327053711 (case), Lot Numbers: 22JBS233, 23FBV585, 23HBG547, 23IBS084; 52) REF DYNJ19417P, UDI/DI 10193489229172 (each) 40193489229173 (case), Lot Numbers: 22FMD662, 22EMB490; 53) REF DYNJ19417Q, UDI/DI 10195327191498 (each) 40195327191499 (case), Lot Numbers: 22GMH186, 22KME324, 22IMD453, 22IMD692, 23BMA309; 54) REF DYNJ19417R, UDI/DI 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23FMC981, 23CMG170; 55) REF DYNJ21569I, UDI/DI 10195327065409 (each) 40195327065400 (case), Lot Numbers: 22JBS386, 23CBD042, 23IBR999; 56) REF DYNJ23432I, UDI/DI 10889942271900 (each) 40889942271901 (case), Lot Numbers: 22DBJ689, 22GBE434, 22JBP085, 23ABR245, 22LBG915, 23CBH756, 23HBQ043, 23DBR693, 23JBH954, 23GBH123, 23LBM769, 24BBR662, 24DBI497, 24EBD713; 57) REF DYNJ24232I, UDI/DI 10195327140731 (each) 40195327140732 (case), Lot Numbers: 22EDB766, 22GDA984; 58) REF DYNJ24232J, UDI/DI 10195327255657 (each) 40195327255658 (case), Lot Numbers: 22JDC162, 23DDA022, 23HDA758, 23IDC299; 59) REF DYNJ24632K, UDI/DI 10195327058623 (each) 40195327058624 (case), Lot Numbers: 22ILA591, 23HLA541, 23FLA748, 23LLA153, 23JLA477, 24BLA432, 23ILA292, 23BLA699, 22JLB138, 23CLB269, 24DLA528, 24CLA719; 60) REF DYNJ24710I, UDI/DI 10195327059392 (each) 40195327059393 (case), Lot Numbers: 22FBU061; 61) REF DYNJ25939N, UDI/DI 10193489835144 (each) 40193489835145 (case), Lot Numbers: 23DMH888; 62) REF DYNJ26693M, UDI/DI 10193489847444 (each) 40193489847445 (case), Lot Numbers: 22JDA742, 22LDC030, 23BDA524; 63) REF DYNJ30064O, UDI/DI 10195327111915 (each) 40195327111916 (case), Lot Numbers: 22FBC579, 22EBG334, 23EBS709, 23CBH779; 64) REF DYNJ30064P, UDI/DI 10195327502164 (each) 40195327502165 (case), Lot Numbers: 23IBS452, 23IBR785; 65) REF DYNJ32229M, UDI/DI 10195327267421 (each) 40195327267422 (case), Lot Numbers: 22KBO766; 66) REF DYNJ32229N, UDI/DI 10195327329082 (each) 40195327329083 (case), Lot Numbers: 23CBV812, 23BBB507, 23ABP901; 67) REF DYNJ32229O, UDI/DI 10195327386306 (each) 40195327386307 (case), Lot Numbers: 23HBB891, 23GBG273, 23FBF959, 23JBG426; 68) REF DYNJ32253G, UDI/DI 10195327066536 (each) 40195327066537 (case), Lot Numbers: 22DBN095, 22LBJ883, 23IBQ192, 23ABD147; 69) REF DYNJ32632F, UDI/DI 10193489888966 (each) 40193489888967 (case), Lot Numbers: 22EMG752, 22LMH944, 23FMI377, 23HMB846; 70) REF DYNJ33059B, UDI/DI 10193489950946 (each) 40193489950947 (case), Lot Numbers: 22HBR300, 22GBC701, 22FBO502, 22IBG828, 23BBA235, 22KBK857, 22JBO407, 23CBI788, 23CBR680; 71) REF DYNJ37535C, UDI/DI 10195327497316 (each) 40195327497317 (case), Lot Numbers: 23IDC191, 23KDB438, 24ADB245, 24CDB018; 72) REF DYNJ37606J, UDI/DI 10195327265939 (each) 40195327265930 (case), Lot Numbers: 22LDB797, 22KDA734, 23BDB037, 23DDA897, 23GDB819, 23IDB695, 23HDC052, 23KDB076, 24ADB757, 24CDA892; 73) REF DYNJ38063D, UDI/DI 10195327034757 (each) 40195327034758 (case), Lot Numbers: 22GMD963, 22FMB090, 23AMH862; 74) REF DYNJ38229C, UDI/DI 10195327381509 (each) 40195327381500 (case), Lot Numbers: 23JBM147; 75) REF DYNJ38700G, UDI/DI 10195327050528 (each) 40195327050529 (case), Lot Numbers: 22LMF294, 22IME584, 22DMG947, 23DMA540, 23EMJ326; 76) REF DYNJ38845D, UDI/DI 10193489860832 (each) 40193489860833 (case), Lot Numbers: 22KBQ263, 22KBH208, 22JBI659, 22GBK750, 23DBO811, 23CBT011; 77) REF DYNJ43024D, UDI/DI 10193489369052 (each) 40193489369053 (case), Lot Numbers: 22GBR079; 78) REF DYNJ43024G, UDI/DI 10195327269128 (each) 40195327269129 (case), Lot Numbers: 22KBM574, 23FBR701, 23EBX483, 24ABQ870, 24DBI502; 79) REF DYNJ43146F, UDI/DI 10195327186463 (each) 40195327186464 (case), Lot Numbers: 22HBD156, 22KBC129, 22LBM266, 22JBT388; 80) REF DYNJ44679L, UDI/DI 10195327127381 (each) 40195327127382 (case), Lot Numbers: 22EBP133, 23DBC683; 81) REF DYNJ44773S, UDI/DI 10195327129132 (each) 40195327129133 (case), Lot Numbers: 22EBD846, 22JBS320, 22EBP297, 22GBG476, 22GBG477; 82) REF DYNJ44773T, UDI/DI 10195327279288 (each) 40195327279289 (case), Lot Numbers: 22KBU616; 83) REF DYNJ44773U, UDI/DI 10195327354398 (each) 40195327354399 (case), Lot Numbers: 23HBN706; 84) REF DYNJ44773V, UDI/DI 10195327510329 (each) 40195327510320 (case), Lot Numbers: 23IBQ950, 23JBR237; 85) REF DYNJ44861K, UDI/DI 10195327151379 (each) 40195327151370 (case), Lot Numbers: 22FDA789, 23HDA148, 23FDC124; 86) REF DYNJ46470F, UDI/DI 10193489690811 (each) 40193489690812 (case), Lot Numbers: 22JBS370; 87) REF DYNJ47808D, UDI/DI 10193489735321 (each) 40193489735322 (case), Lot Numbers: 22GME889, 22FMB414; 88) REF DYNJ47808F, UDI/DI 10195327232603 (each) 40195327232604 (case), Lot Numbers: 22IMB729, 23DMD108, 22KMC639, 23AMH187; 89) REF DYNJ48087F, UDI/DI 10195327138608 (each) 40195327138609 (case), Lot Numbers: 22GBE331, 22KBU611, 23DBQ422, 23DBJ763; 90) REF DYNJ50655I, UDI/DI 10195327652166 (each) 40195327652167 (case), Lot Numbers: 24EBE059; 91) REF DYNJ51354B, UDI/DI 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23AMB096, 22GMC029, 23DMH938, 23CMA391, 23DMG778; 92) REF DYNJ51872D, UDI/DI 10195327043438 (each) 40195327043439 (case), Lot Numbers: 22DBL251, 22GBH469, 22JBI664, 23ABE281, 23FBS138, 23LBM787, 24EBA164; 93) REF DYNJ52387M, UDI/DI 10195327152246 (each) 40195327152247 (case), Lot Numbers: 22EDA354, 22FDA456; 94) REF DYNJ52387N, UDI/DI 10195327339388 (each) 40195327339389 (case), Lot Numbers: 23GDA250, 23CDA137, 23EDC419, 23DDA035, 23HDA585, 23JDA650, 23JDA151; 95) REF DYNJ53528C, UDI/DI 10195327634278 (each) 40195327634279 (case), Lot Numbers: 24DBR747; 96) REF DYNJ53654F, UDI/DI 10193489454673 (each) 40193489454674 (case), Lot Numbers: 22JBD305, 22IBI089; 97) REF DYNJ53654G, UDI/DI 10195327270827 (each) 40195327270828 (case), Lot Numbers: 22KBJ979, 23EBF943, 23GBG336, 23CBD547; 98) REF DYNJ54148D, UDI/DI 10195327107253 (each) 40195327107254 (case), Lot Numbers: 22EME542, 23HMB124, 23FMI401, 23HME182; 99) REF DYNJ54374J, UDI/DI 10193489404074 (each) 40193489404075 (case), Lot Numbers: 22KBM570, 22KBM572, 23DBQ175, 23BBC486; 100) REF DYNJ54374L, UDI/DI 10195327640866 (each) 40195327640867 (case), Lot Numbers: 24DBV819; 101) REF DYNJ56552B, UDI/DI 10193489875782 (each) 40193489875783 (case), Lot Numbers: 22EBG322, 22EBT470, 22GBJ290, 22JBK097, 22KBV496; 102) REF DYNJ59825A, UDI/DI 10195327331610 (each) 40195327331611 (case), Lot Numbers: 23FLA149, 23ALA793, 23CLA305, 23BLA857; 103) REF DYNJ60544C, UDI/DI 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23DBI351; 104) REF DYNJ60813B, UDI/DI 10195327521233 (each) 40195327521234 (case), Lot Numbers: 23KBE890; 105) REF DYNJ61138C, UDI/DI 10195327470319 (each) 40195327470310 (case), Lot Numbers: 23IBN857; 106) REF DYNJ63004A, UDI/DI 10193489245653 (each) 40193489245654 (case), Lot Numbers: 24IMI475, 24CDB780; 107) REF DYNJ63081B, UDI/DI 10195327102128 (each) 40195327102129 (case), Lot Numbers: 22LMI311, 22LMI315, 23AMI423; 108) REF DYNJ63251B, UDI/DI 10193489446715 (each) 40193489446716 (case), Lot Numbers: 23ABC678, 23HBE740, 23IBV029, 24FBQ878, 23KBV883, 24ABK561; 109) REF DYNJ64377D, UDI/DI 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23DBC192, 22LBA830, 22JBU838, 23BBF746, 23CBH805, 23DBA932; 110) REF DYNJ64505B, UDI/DI 10195327115388 (each) 40195327115389 (case), Lot Numbers: 22JBD493, 23EBC123, 23ABI744; 111) REF DYNJ64713A, UDI/DI 10195327026578 (each) 40195327026579 (case), Lot Numbers: 22GDA924, 23BDA541, 23HDA098, 23JDA284, 24ADA914; 112) REF DYNJ64774C, UDI/DI 10195327170288 (each) 40195327170289 (case), Lot Numbers: 22EDB498, 22GDA971; 113) REF DYNJ64774D, UDI/DI 10195327233884 (each) 40195327233885 (case), Lot Numbers: 22KDA633, 23HDA191, 23HDB870; 114) REF DYNJ64775C, UDI/DI 10195327221232 (each) 40195327221233 (case), Lot Numbers: 22KDB451, 22HDC136, 23CDA047, 23ADA701; 115) REF DYNJ64834A, UDI/DI 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23HMG971; 116) REF DYNJ65067B, UDI/DI 10193489317176 (each) 40193489317177 (case), Lot Numbers: 22HMB201, 23BMC083, 23DMA377, 23IMD050, 23LME939, 24FMD904, 24EMF380; 117) REF DYNJ65403A, UDI/DI 10193489417081 (each) 40193489417082 (case), Lot Numbers: 22JBI100, 23CBC321, 23EBO950; 118) REF DYNJ65765A, UDI/DI 10193489420739 (each) 40193489420730 (case), Lot Numbers: 22IBI099, 22GBJ077, 22JBW016, 22GBJ077Z; 119) REF DYNJ67263A, UDI/DI 10195327041090 (each) 40195327041091 (case), Lot Numbers: 22JBA598, 22KBF475, 23JBO817, 23ABE251, 23GBF439; 120) REF DYNJ67263C, UDI/DI 10195327670146 (each) 40195327670147 (case), Lot Numbers: 24CBT303, 24DBQ070; 121) REF DYNJ68547, UDI/DI 10193489836196 (each) 40193489836197 (case), Lot Numbers: 23IBF825, 23HBA364, 23BBC505, 23EBO880, 23GBI454; 122) REF DYNJ68547A, UDI/DI 10195327511784 (each) 40195327511785 (case), Lot Numbers: 23KBP572, 24ABA698, 24ABS249, 24CBU375; 123) REF DYNJ69379, UDI/DI 10193489935769 (each) 40193489935760 (case), Lot Numbers: 22JBP853, 23JBI749, 23JBJ161, 22LBE563, 22LBD098, 24ABD959, 24BBC812, 24BBN636, 23GBI680; 124) REF DYNJ69445, UDI/DI 10193489942514 (each) 40193489942515 (case), Lot Numbers: 23EBF966, 22FBW052, 22JBR185, 23ABD151, 23BBD662; 125) REF DYNJ81604, UDI/DI 10195327123871 (each) 40195327123872 (case), Lot Numbers: 22IBJ792, 22FBC742; 126) REF DYNJ81604A, UDI/DI 10195327314996 (each) 40195327314997 (case), Lot Numbers: 22LBN856, 22LBP341, 23DBS193; 127) REF DYNJ81643, UDI/DI 10195327130060 (each) 40195327130061 (case), Lot Numbers: 22GDB607; 128) REF DYNJ81643B, UDI/DI 10195327353773 (each) 40195327353774 (case), Lot Numbers: 23CDC618, 23HDC367; 129) REF DYNJ82165, UDI/DI 10195327182731 (each) 40195327182732 (case), Lot Numbers: 23ADC047, 23IDA106, 23HDC280, 23FDA439; 130) REF DYNJ82165A, UDI/DI 10195327515317 (each) 40195327515318 (case), Lot Numbers: 23KMJ156, 23JDA589; 131) REF DYNJ82233, UDI/DI 10195327182199 (each) 40195327182190 (case), Lot Numbers: 23HDB847, 23EDB099; 132) REF DYNJ82233A, UDI/DI 10195327499990 (each) 40195327499991 (case), Lot Numbers: 23IDB067, 23JMH533; 133) REF DYNJ82268A, UDI/DI 10195327568757 (each) 40195327568758 (case), Lot Numbers: 24DMI964; 134) REF DYNJ82295, UDI/DI 10195327184278 (each) 40195327184279 (case), Lot Numbers: 23GDB205, 23HDB930; 135) REF DYNJ82295A, UDI/DI 10195327511241 (each) 40195327511242 (case), Lot Numbers: 23JDA502; 136) REF DYNJ82320, UDI/DI 10195327184933 (each) 40195327184934 (case), Lot Numbers: 23CDA350, 23FDA855; 137) REF DYNJ82320A, UDI/DI 10195327499969 (each) 40195327499960 (case), Lot Numbers: 23KME068, 23IDA971; 138) REF DYNJ82949, UDI/DI 10195327218959 (each) 40195327218950 (case), Lot Numbers: 22JBD141, 23CBE053; 139) REF DYNJ83106, UDI/DI 10195327232214 (each) 40195327232215 (case), Lot Numbers: 23CMC503; 140) REF DYNJ83507, UDI/DI 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23ABF423, 23ABE194, 23EBG053, 23FBL255; 141) REF DYNJ83980, UDI/DI 10195327323554 (each) 40195327323555 (case), Lot Numbers: 23CBP050; 142) REF DYNJ85313, UDI/DI 10195327488918 (each) 40195327488919 (case), Lot Numbers: 23JBR932, 23JBP568; 143) REF DYNJ900266D, UDI/DI 10195327348113 (each) 40195327348114 (case), Lot Numbers: 23EBD166; 144) REF DYNJ903355I, UDI/DI 10193489998238 (each) 40193489998239 (case), Lot Numbers: 22HBD351, 23BBP266, 22KBB890, 23BBR616, 23GBU644, 23GBL410, 23GBD887, 23GBD020; 145) REF DYNJ903355J, UDI/DI 10195327501907 (each) 40195327501908 (case), Lot Numbers: 23JBS940, 23JBF685, 23JBN480, 23KBH157, 24BBD228; 146) REF DYNJ903865C, UDI/DI 10193489233001 (each) 40193489233002 (case), Lot Numbers: 22DMA801; 147) REF DYNJ903865D, UDI/DI 10195327239107 (each) 40195327239108 (case), Lot Numbers: 22LMI718, 22LMB688, 23LMG846; 148) REF DYNJ904612F, UDI/DI 10193489844047 (each) 40193489844048 (case), Lot Numbers: 22JBA083, 22GBE050, 23DBD992, 23GBJ657; 149) REF DYNJ904653D, UDI/DI 10193489931075 (each) 40193489931076 (case), Lot Numbers: 22NBC471; 150) REF DYNJ904653F, UDI/DI 10195327108120 (each) 40195327108121 (case), Lot Numbers: 22GBO632, 22HBU927; 151) REF DYNJ904653G, UDI/DI 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23ABE326, 22KBM896, 22KBM559, 23CBU919; 152) REF DYNJ904697F, UDI/DI 10195327169275 (each) 40195327169276 (case), Lot Numbers: 22GDB161, 22HDC380, 23BDB717, 23ADA232, 22LDA193, 23EDA328, 23DDB807; 153) REF DYNJ906263D, UDI/DI 10195327344375 (each) 40195327344376 (case), Lot Numbers: 23EBB469, 23CBJ672, 23GBU448; 154) REF DYNJ906328L, UDI/DI 10195327196103 (each) 40195327196104 (case), Lot Numbers: 23BBA501, 22LBT134, 22JBO208, 23JBD367, 23IBQ441, 23LBQ318, 23DBM840; 155) REF DYNJ906328M, UDI/DI 10195327623203 (each) 40195327623204 (case), Lot Numbers: 24CBJ832, 24BBU373, 24EBB696; 156) REF DYNJ906470D, UDI/DI 10195327204242 (each) 40195327204243 (case), Lot Numbers: 23IDA929; 157) REF DYNJ906572C, UDI/DI 10195327140960 (each) 40195327140961 (case), Lot Numbers: 22IBI024, 22HBR469, 22HBR472, 22FBL440, 22EBF047; 158) REF DYNJ906572D, UDI/DI 10195327325213 (each) 40195327325214 (case), Lot Numbers: 23KBH992, 23IBF632, 23FBC286, 24ABU234; 159) REF DYNJ907073, UDI/DI 10193489337068 (each) 40193489337069 (case), Lot Numbers: 22GBE322, 22KBN515; 160) REF DYNJ907073A, UDI/DI 10195327280437 (each) 40195327280438 (case), Lot Numbers: 22KBU417; 161) REF DYNJ907073B, UDI/DI 10195327319823 (each) 40195327319824 (case), Lot Numbers: 23KBQ319, 23JBK267; 162) REF DYNJ907228F, UDI/DI 10195327247447 (each) 40195327247448 (case), Lot Numbers: 22KBB909, 23BBS431; 163) REF DYNJ907228G, UDI/DI 10195327469290 (each) 40195327469291 (case), Lot Numbers: 23JBB832, 24DBR523, 23KBP254, 23JBW152, 24BBQ286, 24ABO035; 164) REF DYNJ907250A, UDI/DI 10195327267544 (each) 40195327267545 (case), Lot Numbers: 23GBD434, 23HBC400, 23ABM848, 23GBL634, 23FBO421, 23IBU142, 165) REF DYNJ907655A, UDI/DI 10195327017743 (each) 40195327017744 (case), Lot Numbers: 22FBF239; 166) REF DYNJ908312, UDI/DI 10195327091767 (each) 40195327091768 (case), Lot Numbers: 22FBR962, 22HBT675, 23HBG155, 23ABM778, 23KBA371, 23KBA200, 23JBB857; 167) REF DYNJ908327, UDI/DI 10195327036652 (each) 40195327036653 (case), Lot Numbers: 22DMC676, 22GME184, 23CMC342, 23BMF731, 23DMF508; 168) REF DYNJ908818, UDI/DI 10195327185206 (each) 40195327185207 (case), Lot Numbers: 23FDA078, 23DDB584, 23GDC140, 23GDC142, 23JDA969, 23JDA436, 23LME678; 169) REF DYNJ910053, UDI/DI 10195327556693 (each) 40195327556694 (case), Lot Numbers: 24ABE766; 170) REF DYNJ910053A, UDI/DI 10195327589967 (each) 40195327589968 (case), Lot Numbers: 24BBV839, 24BBB305, 24CBS064, 24EBA397; 171) REF DYNJ9932207R, UDI/DI 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23AMB475, 22CMC833, 22DMF261, 22GMB799, 23AMJ375, 23AMG874, 22JMD352, 22IMD536; 172) REF DYNJC2363J, UDI/DI 10195327131340 (each) 40195327131341 (case), Lot Numbers: 22HBI849, 23GBS813, 23CBB008, 22LBQ159, 23IBR864, 23GBG731, 23JBT949; 173) REF DYNJT0181G, UDI/DI 10193489877304 (each) 40193489877305 (case), Lot Numbers: 22DMG525, 23BMH196, 23FMG302; 174) REF DYNJT0473J, UDI/DI 10195327088163 (each) 40195327088164 (case), Lot Numbers: 23AMH668, 23AMF778; 175) REF DYNJT0473K, UDI/DI 10195327438777 (each) 40195327438778 (case), Lot Numbers: 23KMH651, 23HME424, 23FMH389
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email. The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal: https://recalls.medline.com. Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following: "Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002. DO NOT USE THIS COMPONENT. The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*". Those further distributing the product were directed to notify their customers.
• Quantity in Commerce: 58765 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.