Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 86OJF 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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.