MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS... — FDA record Z-0649-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 9, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS940048AG; 13) TOTAL HIP CDS-LF, REF CDS940048AI; 14) TOTAL KNEE, REF CDS940072W; 15) TOTAL KNEE, REF CDS940072Y; 16) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 17) TOTAL KNEE CDS, REF CDS940842Y; 18) TOTAL HIP CDS, REF CDS940843AA; 19) FRACTURE TABLE-LF, REF CDS940857K; 20) FRACTURE TABLE-LF, REF CDS940857L; 21) EXTREMITY-LF, REF CDS940860P; 22) EXTREMITY-LF, REF CDS940860Q; 23) KNEE/SHOULDER, REF CDS940911Q; 24) TOTAL HIP CDS, REF CDS940963Y; 25) SHOULDER CDS, REF CDS941065L; 26) TOTAL JOINT-LF, REF CDS941167M; 27) TOTAL JOINT-LF, REF CDS941167N; 28) LOWER EXTREMITY CDS-LF, REF CDS980666I; 29) LOWER EXTREMITY CDS-LF, REF CDS980666J; 30) TOTAL HIP-LF, REF CDS980788O; 31) TOTAL HIP-LF, REF CDS980788P; 32) EXTREMITY KIT, REF CDS981314R; 33) EXTREMITY KIT, REF CDS981314S; 34) ORIF HIP KIT, REF CDS981318T; 35) ORIF HIP KIT, REF CDS981318U; 36) TOTAL HIP KIT, REF CDS981320V; 37) TOTAL HIP KIT, REF CDS981320W; 38) TOTAL KNEE KIT, REF CDS981323AA; 39) TOTAL KNEE KIT, REF CDS981323Y; 40) BI LATERAL KNEE KIT, REF CDS981324T; 41) UPPER EXTREMITY CDS-LF, REF CDS981564G; 42) UPPER EXTREMITY CDS-LF, REF CDS981564I; 43) LAMI, REF CDS981886X; 44) CRANIOTOMY CDS, REF CDS981888W; 45) CRANIOTOMY CDS, REF CDS981888X; 46) TOTAL KNEE CDS, REF CDS981926D; 47) TOTAL KNEE PROCEDURE-LF, REF CDS982082F; 48) BHMC SYSTEM HIP KIT, REF CDS982396N; 49) BAPTIST NORTH TOTAL KNEE CDS, REF CDS982404M; 50) BAP NORTH SHOULDER CDS, REF CDS982406M; 51) BAP NORTH UNIV EXTREMITY CDS, REF CDS982408K; 52) TOTAL KNEE CDS, REF CDS982823Q; 53) LOWER EXTREMITY CDS-LF, REF CDS982927M; 54) LUMBAR LAMINECTOMY CDS-LF, REF CDS982928O; 55) TOTAL HIP REPLACEMENT CDS-LF, REF CDS982929K; 56) TOTAL KNEE REPLACEMENT CDS-LF, REF CDS982931L; 57) UPPER EXTREMITY-LF, REF CDS982932K; 58) LOWER EXTREMITY CDS, REF CDS982943Q; 59) LOWER EXTREMITY CDS, REF CDS982943R; 60) LOWER EXTREMITY CDS, REF CDS982943S; 61) TOTAL KNEE, REF CDS982986T; 62) SPECIALIZED HIP CDS, REF CDS983030V; 63) EXTREMITY CDS, REF CDS983031Q; 64) ZALE SPINE CDS, REF CDS983182J; 65) ZALE SPINE CDS, REF CDS983182K; 66) ZALE CRANIOTOMY CDS, REF CDS983188K; 67) DR GILL'S CDS, REF CDS983189G; 68) ZALE TOTAL KNEE CDS, REF CDS983194I; 69) ZALE TOTAL KNEE CDS, REF CDS983194J; 70) ZALE TOTAL KNEE CDS, REF CDS983194K; 71) ZALE TOTAL KNEE CDS, REF CDS983194L; 72) ZALE TOTAL HIP CDS, REF CDS983195I; 73) ZALE TOTAL HIP CDS, REF CDS983195J; 74) ZALE TOTAL HIP CDS, REF CDS983195K; 75) ZALE EXTREMITY CDS, REF CDS983199K; 76) ZALE TOTAL SHOULDER CDS, REF CDS983203J; 77) ZALE TOTA...
Reason
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
252162 units
Agency-reported status
Ongoing
Source record identifier
Z-0649-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability86OJF 1) REF CDS780112J, UDI/DI 10195327009663 (each) 40195327009664 (case), Lot Numbers: 22FBF455, 23CBH389, 23FBO500; 2) REF CDS780119V, UDI/DI 10195327114916 (each) 40195327114917 (case), Lot Numbers: 22KBN442, 22HBO015, 23ABF941, 23DBE182, 23BBQ326; 3) REF CDS780147N, UDI/DI 10195327268770 (each) 40195327268771 (case), Lot Numbers: 23DBT165, 22JBU233, 23BBJ852; 4) REF CDS780148Q, UDI/DI 10193489202939 (each) 40193489202930 (case), Lot Numbers: 22JBL294; 5) REF CDS780148R, UDI/DI 10195327268787 (each) 40195327268788 (case), Lot Numbers: 23CBE921, 22LBL862, 23EBA185, 23EBU780; 6) REF CDS920027W, UDI/DI 10193489946956 (each) 40193489946957 (case), Lot Numbers: 22GBL731; 7) REF CDS920027X, UDI/DI 10195327241742 (each) 40195327241743 (case), Lot Numbers: 22JBF953; 8) REF CDS920027Y, UDI/DI 10195327298531 (each) 40195327298532 (case), Lot Numbers: 23CBI608, 23CBF425; 9) REF CDS940047AF, UDI/DI 10195327243890 (each) 40195327243891 (case), Lot Numbers: 23DDC114, 23FDA378, 23IDA521, 23HDB417; 10) REF CDS940047AG, UDI/DI 10195327516710 (each) 40195327516711 (case), Lot Numbers: 23KDA158; 11) REF CDS940048AF, UDI/DI 10195327150259 (each) 40195327150250 (case), Lot Numbers: 22EDB749; 12) REF CDS940048AG, UDI/DI 10195327241896 (each) 40195327241897 (case), Lot Numbers: 22IDA258, 23CDB146, 23IDA944, 23HDA534; 13) REF CDS940048AI, UDI/DI 10195327516703 (each) 40195327516704 (case), Lot Numbers: 23KDA886; 14) REF CDS940072W, UDI/DI 10193489288544 (each) 40193489288545 (case), Lot Numbers: 22DBN494; 15) REF CDS940072Y, UDI/DI 10195327300845 (each) 40195327300846 (case), Lot Numbers: 23EBG408, 23EBE750; 16) REF CDS940823AB, UDI/DI 10193489883282 (each) 40193489883283 (case), Lot Numbers: 22FBP685, 22GBM982, 22FBR756, 23CBS044, 23ABJ584, 22KBN648, 22JBL399, 23EBG438; 17) REF CDS940842Y, UDI/DI 10193489845129 (each) 40193489845120 (case), Lot Numbers: 23EBV624, 23DBT379; 18) REF CDS940843AA, UDI/DI 10195327151409 (each) 40195327151400 (case), Lot Numbers: 22EBD486, 22KBW061, 23DBH163, 23CBV755, 23CBC381, 23EBN012; 19) REF CDS940857K, UDI/DI 10195327247553 (each) 40195327247554 (case), Lot Numbers: 22JBD506, 23ABC389, 23FBM896, 23EBM731; 20) REF CDS940857L, UDI/DI 10195327533311 (each) 40195327533312 (case), Lot Numbers: 23KBF380; 21) REF CDS940860P, UDI/DI 10195327009403 (each) 40195327009404 (case), Lot Numbers: 22FBS102, 22GBM011, 23CBE976, 23CBU516, 23JBH990; 22) REF CDS940860Q, UDI/DI 10195327533304 (each) 40195327533305 (case), Lot Numbers: 23KBX215; 23) REF CDS940911Q, UDI/DI 10195327349073 (each) 40195327349074 (case), Lot Numbers: 23DBD900, 23GBJ502, 23IBB454, 23CBV672, 23GBU420, 23FBR727, 23JBM716, 23JBN033, 23IBV466; 24) REF CDS940963Y, UDI/DI 10193489883671 (each) 40193489883672 (case), Lot Numbers: 22EBN044, 22EBN226, 22GBX355, 22GBR212, 23CBO762, 23BBG535, 22KBE790, 25) REF CDS941065L, UDI/DI 10193489445350 (each) 40193489445351 (case), Lot Numbers: 22KBD585, 23BBN941, 23EBL605; 26) REF CDS941167M, UDI/DI 10195327010454 (each) 40195327010455 (case), Lot Numbers: 22EBM271, 22EBL380, 23ABF515, 23ABD332, 22KBF510, 22IBT122, 23CBU256, 23JBY809, 23JBN695, 23IBC605; 27) REF CDS941167N, UDI/DI 10195327535735 (each) 40195327535736 (case), Lot Numbers: 23KBV806; 28) REF CDS980666I, UDI/DI 10193489485233 (each) 40193489485234 (case), Lot Numbers: 22FME365, 22FMC206, 22JMA036, 23GMB747, 23HMH273, 23KME164, 29) REF CDS980666J, UDI/DI 10195327568566 (each) 40195327568567 (case), Lot Numbers: 24AMF689, 24CME853, 24BMJ472, 24AMJ370, 24DMD132; 30) REF CDS980788O, UDI/DI 10193489233285 (each) 40193489233286 (case), Lot Numbers: 22JLA593, 22LLA050, 23ELA147, 23BLA703; 31) REF CDS980788P, UDI/DI 10195327384722 (each) 40195327384723 (case), Lot Numbers: 24ALA706, 23HLA176, 23GLA079, 23FLA091, 23ELA727, 23LLA549, 23LLB042, 24CLA125, 24DLA497; 32) REF CDS981314R, UDI/DI 10195327080457 (each) 40195327080458 (case), Lot Numbers: 22GMF503, 22KMC777, 22FMF044, 22FMF045, 23HME905, 23GMC775; 33) REF CDS981314S, UDI/DI 10195327539269 (each) 40195327539260 (case), Lot Numbers: 24AMD136; 34) REF CDS981318T, UDI/DI 10195327080174 (each) 40195327080175 (case), Lot Numbers: 23AMD897, 23JMC381; 35) REF CDS981318U, UDI/DI 10195327539245 (each) 40195327539246 (case), Lot Numbers: 23LMA922; 36) REF CDS981320V, UDI/DI 10195327080105 (each) 40195327080106 (case), Lot Numbers: 22GMC259, 22FMI088, 23EMD881, 23EMB534, 23AMC198, 23AME227, 23GME223, 23HMB373, 23KME353; 37) REF CDS981320W, UDI/DI 10195327539306 (each) 40195327539307 (case), Lot Numbers: 23LMG443; 38) REF CDS981323AA, UDI/DI 10195327539313 (each) 40195327539314 (case), Lot Numbers: 24AMC457, 23LMD523; 39) REF CDS981323Y, UDI/DI 10195327080112 (each) 40195327080113 (case), Lot Numbers: 23DME426, 23EMI771, 23JME028, 23JMG482; 40) REF CDS981324T, UDI/DI 10195327080426 (each) 40195327080427 (case), Lot Numbers: 23CMC158, 23CME830; 41) REF CDS981564G, UDI/DI 10193489485226 (each) 40193489485227 (case), Lot Numbers: 22HMA210, 22KMH608, 23AME249, 22LMF194, 23GMB938, 23FME185, 23IMH127, 23IMA748, 23KMI894; 42) REF CDS981564I, UDI/DI 10195327568672 (each) 40195327568673 (case), Lot Numbers: 24BMJ063, 24EMC702, 24DMB943; 43) REF CDS981886X, UDI/DI 10195327145002 (each) 40195327145003 (case), Lot Numbers: 22EBO274, 22JBE914, 22LBF066, 23ABJ993, 23EBS630, 23EBV032, 23JBA693, 23LBB198, 24BBE467, 24CBA388, 24DBK454; 44) REF CDS981888W, UDI/DI 10195327055806 (each) 40195327055807 (case), Lot Numbers: 22DBK058; 45) REF CDS981888X, UDI/DI 10195327144760 (each) 40195327144761 (case), Lot Numbers: 22JBX645, 23DBA432, 23HBT873, 23JBR359, 24DBI356, 24CBD698, 23JBG798, 23JBG925; 46) REF CDS981926D, UDI/DI 10195327141172 (each) 40195327141173 (case), Lot Numbers: 22HBF223, 22GBW207, 22KBO460, 23CBC519, 23BBA923, 23HBP475, 23HBN990, 23EBU765, 23KBF411, 24BBB303, 24EBC197, 24CBK503, 24CBU581; 47) REF CDS982082F, UDI/DI 10193489748765 (each) 40193489748766 (case), Lot Numbers: 22EDB581, 22LDB741, 23CDC093, 23FDB555, 24ADB287, 24DDB001; 48) REF CDS982396N, UDI/DI 10193489985245 (each) 40193489985246 (case), Lot Numbers: 23EBJ391, 23ABH250, 23BBS724, 23GBG962, 23LBF687, 23KBF527, 24BBP516, 24ABE656, 24EBP535, 24EBA091; 49) REF CDS982404M, UDI/DI 10195327010362 (each) 40195327010363 (case), Lot Numbers: 22LBL557, 22JBY563, 23GBG866, 23EBH327, 23JBR515, 23IBG369, 23KBM706, 24ABA228, 24CBA071, 24CBA243, 24DBD789, 24EBF079; 50) REF CDS982406M, UDI/DI 10195327010379 (each) 40195327010370 (case), Lot Numbers: 23ABQ862, 23ABP846, 23EBR980, 23HBX924, 23IBR566, 23IBQ656, 23KBS511, 24BBS092, 24ABV912, 24DBI838; 51) REF CDS982408K, UDI/DI 10195327029159 (each) 40195327029150 (case), Lot Numbers: 22GBU424, 22FBI473, 22FBG543, 23ABC232, 22LBJ951, 22KBU540, 22KBA291, 23HBH304, 23DBD824, 23IBR319, 23EBS632, 24ABV379, 23LBK663, 23KBL500, 24CBB696, 24DBI834, 24EBO787; 52) REF CDS982823Q, UDI/DI 10195327238339 (each) 40195327238330 (case), Lot Numbers: 23ABT038, 22KBT004, 23BBK666; 53) REF CDS982927M, UDI/DI 10193489879155 (each) 40193489879156 (case), Lot Numbers: 22FBX307, 22GBU507, 22JBQ096; 54) REF CDS982928O, UDI/DI 10193489879162 (each) 40193489879163 (case), Lot Numbers: 22GBF591, 22JBI126; 55) REF CDS982929K, UDI/DI 10193489879179 (each) 40193489879170 (case), Lot Numbers: 22GBT440, 22JBH490; 56) REF CDS982931L, UDI/DI 10193489879377 (each) 40193489879378 (case), Lot Numbers: 22GBU520, 22FBG546, 22FBG547, 22GBF485, 22JBH489; 57) REF CDS982932K, UDI/DI 10193489879384 (each) 40193489879385 (case), Lot Numbers: 22GBD664, 22FBU390, 22FBG515; 58) REF CDS982943Q, UDI/DI 10193489363258 (each) 40193489363259 (case), Lot Numbers: 22FBN424; 59) REF CDS982943R, UDI/DI 10195327185268 (each) 40195327185269 (case), Lot Numbers: 23DBR765, 23EBQ503; 60) REF CDS982943S, UDI/DI 10195327432393 (each) 40195327432394 (case), Lot Numbers: 23GBJ647; 61) REF CDS982986T, UDI/DI 10195327175283 (each) 40195327175284 (case), Lot Numbers: 23DBA273, 23ABN818, 23ABJ008, 23FBF632, 23EBG702; 62) REF CDS983030V, UDI/DI 10195327151416 (each) 40195327151417 (case), Lot Numbers: 22GBT329, 22HBL176, 22KBS029; 63) REF CDS983031Q, UDI/DI 10193489848359 (each) 40193489848350 (case), Lot Numbers: 22HBS390, 22JBQ016, 23ABC508, 23EBK971; 64) REF CDS983182J, UDI/DI 10195327147266 (each) 40195327147267 (case), Lot Numbers: 22HBO659, 22GBK869, 22GBK872, 22IBE783; 65) REF CDS983182K, UDI/DI 10195327297503 (each) 40195327297504 (case), Lot Numbers: 23ABB680, 23ABB679, 23DBL294, 23DBL131, 23KBM508, 23JBO877; 66) REF CDS983188K, UDI/DI 10195327105600 (each) 40195327105601 (case), Lot Numbers: 22LBP537, 22JBE497, 22GBZ339, 22GBK865, 23DBF027, 23BBJ482, 22LBS194, 23HBJ188, 23DBG097, 23FBA995, 23IBE032; 67) REF CDS983189G, UDI/DI 10195327164485 (each) 40195327164486 (case), Lot Numbers: 23ABR014, 23JBJ120, 23JBF561, 23HBF458, 23LBQ693; 68) REF CDS983194I, UDI/DI 10193489368017 (each) 40193489368018 (case), Lot Numbers: 22EBG718; 69) REF CDS983194J, UDI/DI 10195327164614 (each) 40195327164615 (case), Lot Numbers: 22FBI875, 22GBO380; 70) REF CDS983194K, UDI/DI 10195327260828 (each) 40195327260829 (case), Lot Numbers: 22LBM727; 71) REF CDS983194L, UDI/DI 10195327379490 (each) 40195327379491 (case), Lot Numbers: 23GBF702; 72) REF CDS983195I, UDI/DI 10193489368024 (each) 40193489368025 (case), Lot Numbers: 22EBI460; 73) REF CDS983195J, UDI/DI 10195327164577 (each) 40195327164578 (case), Lot Numbers: 22GBZ464, 22FBV949, 22GBO379; 74) REF CDS983195K, UDI/DI 10195327297466 (each) 40195327297467 (case), Lot Numbers: 22LBL260; 75) REF CDS983199K, UDI/DI 10195327490140 (each) 40195327490141 (case), Lot Numbers: 23KBF439; 76) REF CDS983203J, UDI/DI 10195327164584 (each) 40195327164585 (case), Lot Numbers: 22GBZ347, 22HBA033, 22GBV925; 77) REF CDS983203K, UDI/DI 10195327260835 (each) 40195327260836 (case), Lot Numbers: 23BBG462, 23DBF658; 78) REF CDS983203L, UDI/DI 10195327379575 (each) 40195327379576 (case), Lot Numbers: 23JBO016, 23JBF453; 79) REF CDS983408G, UDI/DI 10195327150266 (each) 40195327150267 (case), Lot Numbers: 23EDA279, 23CDC647, 23JDC508, 23FDB193; 80) REF CDS983415G, UDI/DI 10195327150181 (each) 40195327150182 (case), Lot Numbers: 22KDC167, 23JDB387, 23JDA841, 23IDA942; 81) REF CDS983416D, UDI/DI 10195327150198 (each) 40195327150199 (case), Lot Numbers: 22GDA312; 82) REF CDS983416G, UDI/DI 10195327279783 (each) 40195327279784 (case), Lot Numbers: 23CDA511; 83) REF CDS983468O, UDI/DI 10195327560959 (each) 40195327560950 (case), Lot Numbers: 24DDA929, 24ADA428, 24EDA794; 84) REF CDS983476J, UDI/DI 10195327497262 (each) 40195327497263 (case), Lot Numbers: 24BDA356, 24ADA401, 23JDA222, 23KDC060, 24DDA670; 85) REF CDS983480G, UDI/DI 10195327497842 (each) 40195327497843 (case), Lot Numbers: 24ADA524, 24CDB716; 86) REF CDS983482L, UDI/DI 10195327497491 (each) 40195327497492 (case), Lot Numbers: 24DBD083, 24BBG190, 24DBD506, 23LBO753; 87) REF CDS983485L, UDI/DI 10195327493073 (each) 40195327493074 (case), Lot Numbers: 23JDB449, 23IDB676, 24ADC157, 23LDB088, 23LDA537, 24CDA450; 88) REF CDS983487K, UDI/DI 10195327493080 (each) 40195327493081 (case), Lot Numbers: 24DDC105, 24ADA398; 89) REF CDS983490M, UDI/DI 10195327493110 (each) 40195327493111 (case), Lot Numbers: 23KDA049, 23IDB775, 24BDA104; 90) REF CDS983610L, UDI/DI 10195327210151 (each) 40195327210152 (case), Lot Numbers: 23HBC818, 23DBE011, 22JBP692, 22KBL228, 23ABS787, 23ABK600; 91) REF CDS983863F, UDI/DI 10195327457600 (each) 40195327457601 (case), Lot Numbers: 23JDC333; 92) REF CDS983907K, UDI/DI 10193489402766 (each) 40193489402767 (case), Lot Numbers: 22GBG415, 22JBQ095; 93) REF CDS983907L, UDI/DI 10195327238346 (each) 40195327238347 (case), Lot Numbers: 23DBN421, 23FBA959, 23FBA960, 23ABJ737, 23ABN875, 23ABR460, 23GBV529, 23FBU350; 94) REF CDS983909O, UDI/DI 10193489402780 (each) 40193489402781 (case), Lot Numbers: 22GBG991, 22GBG385; 95) REF CDS983909P, UDI/DI 10195327238384 (each) 40195327238385 (case), Lot Numbers: 22JBB183, 23BBS793, 22LBL297, 23FBG201, 23EBD620, 23DBD683, 23CBT465, 23GBF419; 96) REF CDS983915L, UDI/DI 10193489402704 (each) 40193489402705 (case), Lot Numbers: 22...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 11, 2024
Recall initiation date
Oct 9, 2024
Center classification date
Dec 5, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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