MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF...
FDA Device Recall #Z-0633-2025 — Class II — October 9, 2024
Recall Summary
| Recall Number | Z-0633-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 25877 units |
Product Description
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
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
Lot / 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
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.