Class 2 Device Recall Medline

• Date Initiated by Firm: October 09, 2024
• Date Posted: December 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0633-2025
• Recall Event ID: 95621
• Product Classification: Plastic surgery and accessories kit - Product Code FTN
• Product: MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC CDS, REF CDS984993P; 13) PLASTIC PACK, REF DYNJ00264L; 14) LKLND BRST CHST PK RFID-LF, REF DYNJ0101536L; 15) OCULOPLASTY PACK-LF, REF DYNJ0252232U; 16) PLASTICS PACK, REF DYNJ02615G; 17) BREAST PBM-LF, REF DYNJ0318423M; 18) FLAP RECONSTRUCTION PACK-LF, REF DYNJ0378388P; 19) BREAST PACK-LF, REF DYNJ0378394R; 20) BREAST PACK-LF, REF DYNJ0378394S; 21) BREAST PACK-LF, REF DYNJ0378394T; 22) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947K; 23) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 24) ASC MAJOR PLASTIC PACK-LF, REF DYNJ0854517M; 25) ASC ENT PLASTIC PACK-LF, REF DYNJ0854650J; 26) BREAST PACK-LF, REF DYNJ0956628M; 27) BREAST PACK-LF, REF DYNJ0956628N; 28) BREAST PACK-LF, REF DYNJ0956628O; 29) AUGMENTATION #87-RF, REF DYNJ27319U; 30) AUGMENTATION #87-RF, REF DYNJ27319V; 31) PLASTICS PACK-LF, REF DYNJ36107J; 32) PLASTIC MINOR PACK, REF DYNJ37620F; 33) CHEST/BREAST PACK, REF DYNJ39118C; 34) PLASTIC BREAST PACK, REF DYNJ40620C; 35) PLASTIC BREAST PACK, REF DYNJ40620D; 36) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 37) BREAST MINOR PK RFID, REF DYNJ52409J; 38) BREAST MAJOR PACK, REF DYNJ52435J; 39) BREAST MAJOR PK RFID, REF DYNJ52435K; 40) BREAST PACK, REF DYNJ57527C; 41) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 42) BREAST PACK SSC, REF DYNJ59733A; 43) BREAST PACK, REF DYNJ60511B; 44) BREAST PACK, REF DYNJ60511F; 45) PLASTIC PACK, REF DYNJ61755B; 46) TYMPANOPLASTY, REF DYNJ63332D; 47) BREAST PACK, REF DYNJ63369D; 48) BREAST SURGERY FOAKS, REF DYNJ63577C; 49) MAJOR PLASTIC FOAKS, REF DYNJ63579C; 50) MAJOR PLASTIC PACK FAIRFAX, REF DYNJ63612C; 51) MAJOR BREAST WOMENS PACK, REF DYNJ63647C; 52) PLASTIC BASIN PACK, REF DYNJ63883B; 53) PLASTICS WOODBURN, REF DYNJ64001B; 54) BREAST PK, REF DYNJ64144B; 55) BREAST PK, REF DYNJ64144C; 56) PACK,PLASTIC, REF DYNJ65477B; 57) PACK,PLASTIC BASIC ASC, REF DYNJ65485A; 58) OSC BREAST PACK, REF DYNJ65808A; 59) CHEST/BREAST PACK, REF DYNJ66495A; 60) PLASTICS PACK, REF DYNJ66610B; 61) BREAST PACK, REF DYNJ66739B; 62) MAJOR PLASTICS PACK, REF DYNJ67968A; 63) BREAST PACK, REF DYNJ68464A; 64) FLAP PACK, REF DYNJ80179A; 65) PLASTICS PACK, REF DYNJ81797A; 66) PLASTICS PACK, REF DYNJ81811A; 67) MINOR PLASTICS PACK, REF DYNJ82196; 68) MINOR PLASTICS PACK, REF DYNJ82196A; 69) DELNOR MAJOR PLASTICS PACK, REF DYNJ82248; 70) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250; 71) DELNOR SIMPLE PLASTIC PACK, REF DYNJ82250A; 72) DELNOR AUGMENTATION PACK, REF DYNJ82265; 73) DELNOR AUGMENTATION PACK, REF DYNJ82265A; 74) AUGMENTATION PACK, REF DYNJ82279; 75) AUGMENTATION PACK, REF DYNJ82279A; 76) PLASTIC SURGERY PACK, REF DYNJ82352; 77) PLASTIC SURGERY PACK, REF DYNJ82352A; 78) FREE FLAP 2 PACK, REF DYNJ82659B; 79) FREE FLAP 1 PACK, REF DYNJ82660A; 80) FREE FLAP 1 PACK, REF DYNJ82660B; 81) FACE PACK, REF DYNJ83532; 82) BREAST RECONSTRUCTION PACK-LF, REF DYNJ83612A; 83) PLASTIC PACK, REF DYNJ83856; 84) BREAST PACK, REF DYNJ84332; 85) MAJOR PLASTIC PACK, REF DYNJ84827; 86) PLASTICS PACK, REF DYNJ84966; 87) PLASTIC PACK, REF DYNJ85702; 88) FACIAL PLASTICS FLAP PACK, REF DYNJ86031; 89) BREAST-CHEST, REF DYNJ900294K; 90) GENERAL PLASTIC-LF, REF DYNJ901738O; 91) TRAM RECONSTRUCTION-LF, REF DYNJ901753L; 92) PLASTIC UNIVERSAL, REF DYNJ901792J; 93) MID HUDSON BREAST, REF DYNJ903614C; 94) MID HUDSON BREAST, REF DYNJ903614D; 95) MID HUDSON BREAST, REF DYNJ903614F; 96) MID HUDSON PLASTICS, REF DYNJ903616F; 97) MID HUDSON PLASTICS, REF DYNJ903616G; 98) MID
• Code Information: 1) REF CDS983478L, UDI/DI 10195327497286 (each) 40195327497287 (case), Lot Numbers: 23JDA999, 23KDB756, 24ADA957, 24DDA553; 2) REF CDS983478M, UDI/DI 10198459000065 (each) 40198459000066 (case), Lot Numbers: 24EDB504; 3) REF CDS983493M, UDI/DI 10195327497415 (each) 40195327497416 (case), Lot Numbers: 23LDA144, 24ADA328; 4) REF CDS983496L, UDI/DI 10195327497408 (each) 40195327497409 (case), Lot Numbers: 23KDC085, 24ADB601; 5) REF CDS983496M, UDI/DI 10198459000201 (each) 40198459000202 (case), Lot Numbers: 24EDA817; 6) REF CDS983498N, UDI/DI 10198459000188 (each) 40198459000189 (case), Lot Numbers: 24EDA816; 7) REF CDS983639J, UDI/DI 10195327228149 (each) 40195327228140 (case), Lot Numbers: 22IBF012, 22IBF004, 22LBE960, 22KBK687; 8) REF CDS983639K, UDI/DI 10195327351533 (each) 40195327351534 (case), Lot Numbers: 23EBA182, 23EBN996, 23CBV828, 23FBP157, 23FBH151; 9) REF CDS984267J, UDI/DI 10193489288872 (each) 40193489288873 (case), Lot Numbers: 22GBR052, 22FBG539, 22KBU660, 23ABL613, 23DBD827; 10) REF CDS984993N, UDI/DI 10195327031114 (each) 40195327031115 (case), Lot Numbers: 22EBV339; 11) REF CDS984993O, UDI/DI 10195327175764 (each) 40195327175765 (case), Lot Numbers: 22GBF349, 22JBJ441, 23BBV017, 23EBN595, 23IBU110, 23GBE740, 23GBE766, 23IBC614, 23LBC779, 23KBH710; 12) REF CDS984993P, UDI/DI 10195327588007 (each) 40195327588008 (case), Lot Numbers: 24ABH482, 24DBD860; 13) REF DYNJ00264L, UDI/DI 10193489942019 (each) 40193489942010 (case), Lot Numbers: 22IMH644, 22EMF495, 23AMB776, 22FMD650, 23CMA570, 22KME942; 14) REF DYNJ0101536L, UDI/DI 10195327333041 (each) 40195327333042 (case), Lot Numbers: 23IMB288; 15) REF DYNJ0252232U, UDI/DI 10193489954111 (each) 40193489954112 (case), Lot Numbers: 22FMI316, 22EMD248, 23EMF255, 23HMB707, 23AME630, 23IMA845, 23DMC649, 23IMG327, 23JMI300; 16) REF DYNJ02615G, UDI/DI 10195327291051 (each) 40195327291052 (case), Lot Numbers: 23JMJ208; 17) REF DYNJ0318423M, UDI/DI 10193489442687 (each) 40193489442688 (case), Lot Numbers: 22LMH207, 22JMG688, 23LMB715, 23EMJ272; 18) REF DYNJ0378388P, UDI/DI 10195327089979 (each) 40195327089970 (case), Lot Numbers: 22DBK643, 22DBI785, 23BBC753, 22LBO807, 23CBT793, 23HBY759, 23HBA704; 19) REF DYNJ0378394R, UDI/DI 10195327089900 (each) 40195327089901 (case), Lot Numbers: 22EBM867; 20) REF DYNJ0378394S, UDI/DI 10195327187958 (each) 40195327187959 (case), Lot Numbers: 22FBP935, 22LBO853, 23DBB583, 23EBE187, 23DBJ565, 23FBG607, 23GBH212; 21) REF DYNJ0378394T, UDI/DI 10195327498306 (each) 40195327498307 (case), Lot Numbers: 23IBJ701, 23JBP685; 22) REF DYNJ0428947K, UDI/DI 10195327055578 (each) 40195327055579 (case), Lot Numbers: 22CLB388, 22EMG126, 22ELA518, 22KME295, 22HME064; 23) REF DYNJ0428947L, UDI/DI 10195327329136 (each) 40195327329137 (case), Lot Numbers: 23EMH835, 23CMC033, 23BMD726; 24) REF DYNJ0854517M, UDI/DI 10193489832419 (each) 40193489832410 (case), Lot Numbers: 22HMC268, 22IME146, 23BMD202, 23EMD923, 23FME798, 23JMF894, 24BMD822, 23GMH631, 24DMD934, 23KMI567, 23IMG202, 24CMC965; 25) REF DYNJ0854650J, UDI/DI 10193489832426 (each) 40193489832427 (case), Lot Numbers: 22KMF904, 22JMA456, 23EMD925, 23BMA380, 23LMI046, 23KMJ020, 24BMB393; 26) REF DYNJ0956628M, UDI/DI 10195327117955 (each) 40195327117956 (case), Lot Numbers: 22FMI331; 27) REF DYNJ0956628N, UDI/DI 10195327216450 (each) 40195327216451 (case), Lot Numbers: 22JMB058, 22LMD532, 23AMG987, 23BMC748; 28) REF DYNJ0956628O, UDI/DI 10195327416133 (each) 40195327416134 (case), Lot Numbers: 23HMH285, 23GMI738, 23EMI827, 23IMG042, 23LMA088, 23KMF814, 24BMG288, 23LMF199, 23LMF199A, 24DMF169; 29) REF DYNJ27319U, UDI/DI 10195327104528 (each) 40195327104529 (case), Lot Numbers: 22DBE822, 22DBT722; 30) REF DYNJ27319V, UDI/DI 10195327208127 (each) 40195327208128 (case), Lot Numbers: 22IBJ843, 22IBJ845, 23DBJ736, 23ABF396, 22GBY108, 23EBW485, 23EBQ342; 31) REF DYNJ36107J, UDI/DI 10195327080273 (each) 40195327080274 (case), Lot Numbers: 22FMH984; 32) REF DYNJ37620F, UDI/DI 10195327497392 (each) 40195327497393 (case), Lot Numbers: 23JDA165, 23LDA934, 24CDA370; 33) REF DYNJ39118C, UDI/DI 10195327509750 (each) 40195327509751 (case), Lot Numbers: 23JBT477; 34) REF DYNJ40620C, UDI/DI 10193489699692 (each) 40193489699693 (case), Lot Numbers: 23CBV601, 23CBH954, 23EBT508; 35) REF DYNJ40620D, UDI/DI 10195327435776 (each) 40195327435777 (case), Lot Numbers: 23JBP045; 36) REF DYNJ44852M, UDI/DI 10195327325220 (each) 40195327325221 (case), Lot Numbers: 23AMC530, 23AMC374, 23CMF343, 23FMH424; 37) REF DYNJ52409J, UDI/DI 10195327339203 (each) 40195327339204 (case), Lot Numbers: 23DDB215, 23GDB232; 38) REF DYNJ52435J, UDI/DI 10195327222819 (each) 40195327222810 (case), Lot Numbers: 22KDA287; 39) REF DYNJ52435K, UDI/DI 10195327339630 (each) 40195327339631 (case), Lot Numbers: 23EDA425, 23GDC225, 23IDA847; 40) REF DYNJ57527C, UDI/DI 10195327243470 (each) 40195327243471 (case), Lot Numbers: 23ABG344, 23BBS780; 41) REF DYNJ58257G, UDI/DI 10193489968644 (each) 40193489968645 (case), Lot Numbers: 22EMA050, 22JME557, 22HMH771, 22LMD593, 23CMC086; 42) REF DYNJ59733A, UDI/DI 10195327206413 (each) 40195327206414 (case), Lot Numbers: 22LBI106; 43) REF DYNJ60511B, UDI/DI 10195327134976 (each) 40195327134977 (case), Lot Numbers: 22EBL029; 44) REF DYNJ60511F, UDI/DI 10195327352332 (each) 40195327352333 (case), Lot Numbers: 23CBB490, 23IBU091, 23IBI131, 23JBM061; 45) REF DYNJ61755B, UDI/DI 10195327149550 (each) 40195327149551 (case), Lot Numbers: 22FMG692, 23BMB157, 22JMD332, 22HMF130, 22KMG291; 46) REF DYNJ63332D, UDI/DI 10195327062675 (each) 40195327062676 (case), Lot Numbers: 22DBL674, 22GBC932; 47) REF DYNJ63369D, UDI/DI 10195327273354 (each) 40195327273355 (case), Lot Numbers: 23BMA188, 23JMG362; 48) REF DYNJ63577C, UDI/DI 10195327122850 (each) 40195327122851 (case), Lot Numbers: 22EBT513, 22GBV398, 23IBQ212, 23JBG821; 49) REF DYNJ63579C, UDI/DI 10195327122867 (each) 40195327122868 (case), Lot Numbers: 23HBP091, 23IBT926; 50) REF DYNJ63612C, UDI/DI 10195327350291 (each) 40195327350292 (case), Lot Numbers: 23FBE254, 23IBN288, 23GBT338; 51) REF DYNJ63647C, UDI/DI 10195327350406 (each) 40195327350407 (case), Lot Numbers: 23HBI038, 23CBU235, 23FBR630; 52) REF DYNJ63883B, UDI/DI 10195327014148 (each) 40195327014149 (case), Lot Numbers: 22DDA800, 22EDB037; 53) REF DYNJ64001B, UDI/DI 10195327178062 (each) 40195327178063 (case), Lot Numbers: 22GBW636, 22FBR610, 23JBG814, 23IBN289; 54) REF DYNJ64144B, UDI/DI 10195327366773 (each) 40195327366774 (case), Lot Numbers: 23FBF133, 23GBQ526; 55) REF DYNJ64144C, UDI/DI 10195327513023 (each) 40195327513024 (case), Lot Numbers: 23JBL674; 56) REF DYNJ65477B, UDI/DI 10195327303440 (each) 40195327303441 (case), Lot Numbers: 23AMG835, 23HMC960, 23IME795; 57) REF DYNJ65485A, UDI/DI 10195327303433 (each) 40195327303434 (case), Lot Numbers: 23HMG237; 58) REF DYNJ65808A, UDI/DI 10193489949803 (each) 40193489949804 (case), Lot Numbers: 22FBD780, 22FBX439; 59) REF DYNJ66495A, UDI/DI 10195327247584 (each) 40195327247585 (case), Lot Numbers: 22JMB371, 23BMH635; 60) REF DYNJ66610B, UDI/DI 10195327429140 (each) 40195327429141 (case), Lot Numbers: 23GBF354, 23KBC530, 23HBV806, 24ABW336, 24BBN977, 24DBF700, 24CBN383; 61) REF DYNJ66739B, UDI/DI 10195327504441 (each) 40195327504442 (case), Lot Numbers: 23KBM905, 23LBR954; 62) REF DYNJ67968A, UDI/DI 10193489962949 (each) 40193489962940 (case), Lot Numbers: 22IMF531, 22GMG777, 23BMC966, 23DMA746; 63) REF DYNJ68464A, UDI/DI 10195327261665 (each) 40195327261666 (case), Lot Numbers: 23ABL973, 23ABK919, 23ABH279, 22LBJ691, 23BBE426, 23FBH839; 64) REF DYNJ80179A, UDI/DI 10195327194949 (each) 40195327194940 (case), Lot Numbers: 22LBJ892, 23BBU702, 22IBJ389, 23FBC812; 65) REF DYNJ81797A, UDI/DI 10195327515973 (each) 40195327515974 (case), Lot Numbers: 23KBD075, 23IBT729, 23LBM384, 24BBC801, 24BBG132, 24CBK447, 24CBC579; 66) REF DYNJ81811A, UDI/DI 10195327681562 (each) 40195327681563 (case), Lot Numbers: 24DBK129; 67) REF DYNJ82196, UDI/DI 10195327183509 (each) 40195327183500 (case), Lot Numbers: 23DDB164, 23GDB788, 23HDB846; 68) REF DYNJ82196A, UDI/DI 10195327519827 (each) 40195327519828 (case), Lot Numbers: 23LMG620, 23JDA365; 69) REF DYNJ82248, UDI/DI 10195327181741 (each) 40195327181742 (case), Lot Numbers: 23GDA030, 23GDA857; 70) REF DYNJ82250, UDI/DI 10195327181758 (each) 40195327181759 (case), Lot Numbers: 23FDA957, 23HDB240; 71) REF DYNJ82250A, UDI/DI 10195327528584 (each) 40195327528585 (case), Lot Numbers: 23KME039; 72) REF DYNJ82265, UDI/DI 10195327182274 (each) 40195327182275 (case), Lot Numbers: 23FDA050; 73) REF DYNJ82265A, UDI/DI 10195327528393 (each) 40195327528394 (case), Lot Numbers: 23JMJ376, 23KMH770; 74) REF DYNJ82279, UDI/DI 10195327183950 (each) 40195327183951 (case), Lot Numbers: 23GDB647, 23IMF720; 75) REF DYNJ82279A, UDI/DI 10195327545161 (each) 40195327545162 (case), Lot Numbers: 23KMF508; 76) REF DYNJ82352, UDI/DI 10195327186630 (each) 40195327186631 (case), Lot Numbers: 23DDA656, 23IDA294, 23FDA737; 77) REF DYNJ82352A, UDI/DI 10195327545772 (each) 40195327545773 (case), Lot Numbers: 23KMD874; 78) REF DYNJ82659B, UDI/DI 10195327557799 (each) 40195327557790 (case), Lot Numbers: 23LBH530, 24BBO870; 79) REF DYNJ82660A, UDI/DI 10195327489687 (each) 40195327489688 (case), Lot Numbers: 23JBD568; 80) REF DYNJ82660B, UDI/DI 10195327557706 (each) 40195327557707 (case), Lot Numbers: 23KBL438, 24ABN390, 24BBI263; 81) REF DYNJ83532, UDI/DI 10195327276416 (each) 40195327276417 (case), Lot Numbers: 23FBL704, 23HBL044, 23JBI232, 23KBI654; 82) REF DYNJ83612A, UDI/DI 10195327433703 (each) 40195327433704 (case), Lot Numbers: 23KMI546, 23IMG920, 23GMI169; 83) REF DYNJ83856, UDI/DI 10195327318253 (each) 40195327318254 (case), Lot Numbers: 23FBO433, 23FBO778, 23CBM467; 84) REF DYNJ84332, UDI/DI 10195327353117 (each) 40195327353118 (case), Lot Numbers: 23DMB713; 85) REF DYNJ84827, UDI/DI 10195327425272 (each) 40195327425273 (case), Lot Numbers: 23HBE654, 23EBX040, 23JBI656; 86) REF DYNJ84966, UDI/DI 10195327441821 (each) 40195327441822 (case), Lot Numbers: 23JBJ781, 23KBB702, 23JBW571, 23KBG577; 87) REF DYNJ85702, UDI/DI 10195327536213 (each) 40195327536214 (case), Lot Numbers: 24ABP053, 24DBR982; 88) REF DYNJ86031, UDI/DI 10195327581633 (each) 40195327581634 (case), Lot Numbers: 24BLB039; 89) REF DYNJ900294K, UDI/DI 10193489915150 (each) 40193489915151 (case), Lot Numbers: 22KBP158, 23ABM718, 22JBS854, 23EBF969, 23EBR997; 90) REF DYNJ901738O, UDI/DI 10195327495930 (each) 40195327495931 (case), Lot Numbers: 24ADA162, 23KDA408; 91) REF DYNJ901753L, UDI/DI 10195327496180 (each) 40195327496181 (case), Lot Numbers: 24BDA185, 23LDB476; 92) REF DYNJ901792J, UDI/DI 10195327546564 (each) 40195327546565 (case), Lot Numbers: 24AMJ347, 23LMD856; 93) REF DYNJ903614C, UDI/DI 10193489280234 (each) 40193489280235 (case), Lot Numbers: 22GBY708; 94) REF DYNJ903614D, UDI/DI 10195327237516 (each) 40195327237517 (case), Lot Numbers: 23ABM705; 95) REF DYNJ903614F, UDI/DI 10195327368371 (each) 40195327368372 (case), Lot Numbers: 24CBH093, 23HBD137, 24DBR891; 96) REF DYNJ903616F, UDI/DI 10195327237530 (each) 40195327237531 (case), Lot Numbers: 23BBB789; 97) REF DYNJ903616G, UDI/DI 10195327372262 (each) 40195327372263 (case), Lot Numbers: 23IBG231, 23IBG829, 23HBN599, 23EBI668, 23FBB347, 24BBG027, 23GBS726; 98) REF DYNJ903616I, UDI/DI 10195327648374 (each) 40195327648375 (case), Lot Numbers: 24DBL776; 99) REF DYNJ903616J, UDI/DI 10198459007279 (each) 40198459007270 (case), Lot Numbers: 24IBL099, 24HBL800, 24GBK425; 100) REF DYNJ906471F, UDI/DI 10195327210946 (each) 40195327210947 (case), Lot Numbers: 22IDB704, 22LDB605, 23IDB173; 101) REF DYNJ907141A, UDI/DI 10193489999938 (each) 40193489999939 (case), Lot Numbers: 22FBM161, 22FBG627, 22GBY527, 22JBR768, 23ABQ820, 23ABE732, 23EBU779, 23EBA967, 23CBW388; 102) REF DYNJ907141B, UDI/DI 10195327450434 (each) 40195327450435 (case), Lot Numbers: 23HBA138; 103) REF DYNJ907410A, UDI/DI 10195327335823 (each) 40195327335824 (case), Lot Numbers: 23EMD893; 104) REF DYNJ907410B, UDI/DI 10195327462222 (each) 40195327462223 (case), Lot Numbers: 23HMF127, 23IMF385; 105) REF DYNJ907791B, UDI/DI 10195327185237 (each) 40195327185238 (case), Lot Numbers: 22JBN762, 22GBK931, 22KBE789, 22KBB846, 23CBN749, 23CBJ391, 23CBE960, 23DBM205; 106) REF DYNJ907791D, UDI/DI 10195327439859 (each) 40195327439850 (case), Lot Numbers: 23GBB518; 107) REF DYNJ908058A, UDI/DI 10195327125424 (each) 40195327125425 (case), Lot Numbers: 22GBM150, 22FBR755, 22FBM688, 22LBC294, 22KBF561, 22JBE835, 23ABM655, 23EBA419; 108) REF DYNJ908258C, UDI/DI 10195327243876 (each) 40195327243877 (case), Lot Numbers: 23FDA366, 23HDA578, 23JDB900; 109) REF DYNJ908691A, UDI/DI 10195327515911 (each) 40195327515912 (case), Lot Numbers: 23LBQ414, 24DBA370; 110) REF DYNJ908729, UDI/DI 10195327159221 (each) 40195327159222 (case), Lot Numbers: 22GBV793, 23EBI552, 23HBS915, 23HBS528, 23JBV713, 23LBH123, 24ABW912, 24ABF765; 111) REF DYNJ908729A, UDI/DI 10195327641375 (each) 40195327641376 (case), Lot Numbers: 24CBP680, 24DBS149; 112) REF DYNJ908790, UDI/DI 10195327183295 (each) 40195327183296 (case), Lot Numbers: 23CDB747, 23CDA590, 23GDA891, 23IDB773; 113) REF DYNJ908790A, UDI/DI 10195327520410 (each) 40195327520411 (case), Lot Numbers: 24AME679; 114) REF DYNJ908839, UDI/DI 10195327184438 (each) 40195327184439 (case), Lot Numbers: 23ABT334, 23ABL506; 115) REF DYNJ909203, UDI/DI 10195327304065 (each) 40195327304066 (case), Lot Numbers: 23BBG452; 116) REF DYNJ909410, UDI/DI 10195327338473 (each) 40195327338474 (case), Lot Numbers: 23FMI603; 117) REF DYNJ909786, UDI/DI 10195327475802 (each) 40195327475803 (case), Lot Numbers: 23IBK726; 118) REF DYNJ9426113M, UDI/DI 10195327057114 (each) 40195327057115 (case), Lot Numbers: 22FLA762, 23CMF426; 119) REF DYNJVB91043, UDI/DI 10193489284454 (each) 40193489284455 (case), Lot Numbers: 22GDA314, 22IDA697
• 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: 25877 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.