Recall archive / FDA device enforcement
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS76005... — FDA record Z-0630-2025
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: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS920080S; 13) BASIC LAPAROSCOPY CDS, REF CDS920080T; 14) GENERAL LAPAROSCOPY, REF CDS930027U; 15) GENERAL LAPAROSCOPY, REF CDS930027V; 16) MINOR BASIC-LF, REF CDS930120G; 17) MINOR BASIC-LF, REF CDS930120I; 18) MAJOR DRAPE-LF, REF CDS930121L; 19) GENERAL LAPAROSCOPY PROCEDURE, REF CDS930125U; 20) GENERAL MINOR CDS, REF CDS980246V; 21) MAJOR PROCEDURE-LF, REF CDS980255T; 22) MAJOR LAPAROTOMY, REF CDS981133K; 23) MAJOR LAPAROTOMY KIT, REF CDS981316T; 24) MINOR KIT, REF CDS981317V; 25) BAPTIST NORTH MAJOR CDS, REF CDS982410L; 26) MINOR PROCEDURE CDS-LF, REF CDS982923N; 27) GEN SURG LAPAROSCOPY CDS-LF, REF CDS982926L; 28) LAPAROTOMY CDS, REF CDS983412I; 29) GENERAL LAPAROSCOPY CDS, REF CDS983418I; 30) MINOR-LF, REF CDS983862D; 31) MAJOR ABDOMINAL CDS, REF CDS983908P; 32) LAP CHOLE CDS, REF CDS983912W; 33) LAP CHOLE CDS, REF CDS983912X; 34) GENERAL SURGERY CDS, REF CDS983914L; 35) NHP GENERAL LAPAROSCOPY CDS, REF CDS984232I; 36) GENERAL LAP, REF CDS984251N; 37) ROBOTIC, REF CDS984262M; 38) MINOR CDS, REF CDS984274K; 39) MINOR CDS, REF CDS984274L; 40) MAJOR CDS, REF CDS984277L; 41) MAJOR CDS, REF CDS984277M; 42) SMH MAJOR CDS, REF CDS984588L; 43) MAJOR CDS-LF, REF CDS984599G; 44) MINOR CDS-LF, REF CDS984600G; 45) MINOR PROCEDURE, REF CDS984897K; 46) MINOR PROCEDURE, REF CDS984897L; 47) GENERAL LAPAROSCOPY CDS, REF CDS984901K; 48) GENERAL LAPAROSCOPY CDS, REF CDS984901L; 49) GENERAL LAPAROSCOPY CDS, REF CDS984901M; 50) DAY SURG MAJOR CDS, REF CDS984994M; 51) DAY SURG MAJOR CDS, REF CDS984994N; 52) MINOR SURGERY CDS, REF CDS985321K; 53) LAPAROTOMY CDS-LF, REF CDS985327I; 54) GENERAL LAPAROSCOPY CDS, REF CDS985328J; 55) LAP MAJOR, REF CDS985348F; 56) GENERAL LAPAROSCOPY CDS, REF CDS985422J; 57) GENERAL LAPAROSCOPY CDS, REF CDS985422K; 58) LAPAROTOMY CDS, REF CDS985426I; 59) LAPAROTOMY CDS, REF CDS985426J; 60) LAPAROTOMY CDS, REF CDS985426K; 61) ACH MINOR PROCEDURE, REF CDS985451G; 62) ACH MAJOR ABDOMINAL, REF CDS985454I; 63) SCOPE LAP THOR PACK, REF DYNJ00210L; 64) SCOPE LAP THOR PACK, REF DYNJ00210M; 65) MAJOR LAPAROTOMY PACK, REF DYNJ00387O; 66) GER LAPTMPK RFID-LF, REF DYNJ0100957K; 67) LAKELAND HERNIA PACK RFID-LF, REF DYNJ0101477K; 68) SJ EXPLORATORY LAP PACK-LF, REF DYNJ0101482I; 69) SJ EXPLRTRY LP PK RFID-LF, REF DYNJ0101482J; 70) MINOR PACK-LF, REF DYNJ0105608G; 71) LAPAROTOMY PACK-LF, REF DYNJ0161299C; 72) CYSTO PACK, REF DYNJ01920N; 73) LAP CHOLE PACK, REF DYNJ02458P; 74) OPEN HERNIA APPY PACK, REF DYNJ02575F; 75) GENERAL ABDOMINAL PACK-LF, REF DYNJ0271195S; 76) LAPAROT...
- 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
- 167074 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0630-2025
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 | 1) REF CDS760057J, UDI/DI 10195327008963 (each) 40195327008964 (case), Lot Numbers: 22FBX954, 22FBE976; 2) REF CDS760057K, UDI/DI 10195327274368 (each) 40195327274369 (case), Lot Numbers: 23ABU244, 22LBC409, 23GBN928, 23CBO552, 23EBA183, 23JBH987; 3) REF CDS760057L, UDI/DI 10195327533373 (each) 40195327533374 (case), Lot Numbers: 23KBL294; 4) REF CDS860015W, UDI/DI 10195327349509 (each) 40195327349500 (case), Lot Numbers: 23FBP597; 5) REF CDS860016P, UDI/DI 10193489848007 (each) 40193489848008 (case), Lot Numbers: 22FBQ637; 6) REF CDS860016Q, UDI/DI 10195327209599 (each) 40195327209590 (case), Lot Numbers: 23ABM653, 22KBA835, 22JBE511; 7) REF CDS860016R, UDI/DI 10195327349479 (each) 40195327349470 (case), Lot Numbers: 23GBD634; 8) REF CDS860062R, UDI/DI 10193489852073 (each) 40193489852074 (case), Lot Numbers: 22OBE627, 22OBA906; 9) REF CDS860062S, UDI/DI 10195327140632 (each) 40195327140633 (case), Lot Numbers: 22GBS435, 22GBO814, 23ABG350, 23DBG817, 23EBQ675; 10) REF CDS860194I, UDI/DI 10193489445152 (each) 40193489445153 (case), Lot Numbers: 22GBN008, 23BBR005, 22LBJ448, 22JBH327, 23GBL900, 23GBM243, 23DBE016, 22KBK702; 11) REF CDS920080R, UDI/DI 10195327079086 (each) 40195327079087 (case), Lot Numbers: 22GBZ014, 22GBD101; 12) REF CDS920080S, UDI/DI 10195327209605 (each) 40195327209606 (case), Lot Numbers: 23ABK590, 22JBO105; 13) REF CDS920080T, UDI/DI 10195327349486 (each) 40195327349487 (case), Lot Numbers: 23EBB523; 14) REF CDS930027U, UDI/DI 10193489288537 (each) 40193489288538 (case), Lot Numbers: 22FBY534; 15) REF CDS930027V, UDI/DI 10195327241759 (each) 40195327241750 (case), Lot Numbers: 22JBR529, 22JBJ699, 23CBP730, 23ABL590, 23FBV023; 16) REF CDS930120G, UDI/DI 10195327009649 (each) 40195327009640 (case), Lot Numbers: 22FBV562, 22IBU622, 22KBI260, 22LBT330, 23HBS920, 23HBS779, 23ABQ984, 23EBD647, 23JBJ078; 17) REF CDS930120I, UDI/DI 10195327533342 (each) 40195327533343 (case), Lot Numbers: 23KBP659; 18) REF CDS930121L, UDI/DI 10195327065423 (each) 40195327065424 (case), Lot Numbers: 22HBW307, 22FBY076, 22FBL423, 22FBD509, 23ABE056, 23DBD811, 23GBH847, 23GBD235; 19) REF CDS930125U, UDI/DI 10195327070649 (each) 40195327070640 (case), Lot Numbers: 22GBU110; 20) REF CDS980246V, UDI/DI 10193489848342 (each) 40193489848343 (case), Lot Numbers: 22FBG654, 22GBG438, 22JBP742, 23ABC247, 23ABA732, 24ABW634, 23BBR708; 21) REF CDS980255T, UDI/DI 10195327070953 (each) 40195327070954 (case), Lot Numbers: 22EBM326; 22) REF CDS981133K, UDI/DI 10193489232790 (each) 40193489232791 (case), Lot Numbers: 22GBS136, 23ABN806, 23FBD728, 23EBG698; 23) REF CDS981316T, UDI/DI 10195327080327 (each) 40195327080328 (case), Lot Numbers: 23AMF056, 22IMG471, 22IMC654, 22GMF154, 23AMA166, 23GMD409, 23JME751; 24) REF CDS981317V, UDI/DI 10195327080334 (each) 40195327080335 (case), Lot Numbers: 23AME149, 23EME454, 23DMI523, 23DMH375, 23DMF969, 23JMG478, 23GMF034; 25) REF CDS982410L, UDI/DI 10195327010355 (each) 40195327010356 (case), Lot Numbers: 22FBY050, 22FBG767, 22LBL902, 22JBQ938, 22GBX571, 23ABS820, 23GBF802, 23HBH768, 23JBF446, 23FBG106, 23LBC743, 23LBV791, 24BBC919, 24CBI845, 24DBL164; 26) REF CDS982923N, UDI/DI 10193489879131 (each) 40193489879132 (case), Lot Numbers: 22GBB143, 22HBA841, 22JBA827; 27) REF CDS982926L, UDI/DI 10193489879148 (each) 40193489879149 (case), Lot Numbers: 22EBV223, 22HBU923, 22GBQ030, 22JBH491; 28) REF CDS983412I, UDI/DI 10195327150280 (each) 40195327150281 (case), Lot Numbers: 22EDB850, 22KDB573, 23JDC515, 23IDA592; 29) REF CDS983418I, UDI/DI 10195327150211 (each) 40195327150212 (case), Lot Numbers: 22HDA811, 22HDA635, 23FDC269; 30) REF CDS983862D, UDI/DI 10195327457594 (each) 40195327457595 (case), Lot Numbers: 23HDB005; 31) REF CDS983908P, UDI/DI 10195327238322 (each) 40195327238323 (case), Lot Numbers: 22IBE804, 23ABR067, 23EBS477; 32) REF CDS983912W, UDI/DI 10195327238407 (each) 40195327238408 (case), Lot Numbers: 22KBI248, 23CBC518, 22LBL513, 23DBM244; 33) REF CDS983912X, UDI/DI 10195327403140 (each) 40195327403141 (case), Lot Numbers: 23EBK644; 34) REF CDS983914L, UDI/DI 10195327238360 (each) 40195327238361 (case), Lot Numbers: 22KBS109, 22JBB309, 22JBR865, 23DBS264, 23FBB365; 35) REF CDS984232I, UDI/DI 10193489872316 (each) 40193489872317 (case), Lot Numbers: 22GBH700; 36) REF CDS984251N, UDI/DI 10193489862218 (each) 40193489862219 (case), Lot Numbers: 22FBY535, 22DBU825, 22DBU035, 22JBJ429, 22IBE900, 23ABL588, 23ABA711; 37) REF CDS984262M, UDI/DI 10193489862416 (each) 40193489862417 (case), Lot Numbers: 22EBF874, 22FBR235, 22FBD543, 22IBF745; 38) REF CDS984274K, UDI/DI 10195327291488 (each) 40195327291489 (case), Lot Numbers: 23AMA140, 23AMG079, 23DMH790, 23FMA956; 39) REF CDS984274L, UDI/DI 10195327439040 (each) 40195327439041 (case), Lot Numbers: 23KMC240, 23JME574; 40) REF CDS984277L, UDI/DI 10195327291518 (each) 40195327291519 (case), Lot Numbers: 23AMF980, 23FMC898, 23DMH791; 41) REF CDS984277M, UDI/DI 10195327438944 (each) 40195327438945 (case), Lot Numbers: 23JMB551, 23IMH840, 23IMC562; 42) REF CDS984588L, UDI/DI 10195327103439 (each) 40195327103430 (case), Lot Numbers: 22KBG367; 43) REF CDS984599G, UDI/DI 10195327568641 (each) 40195327568642 (case), Lot Numbers: 24CMI303, 24BMC869, 24AME713, 24BMK193, 24EMC288; 44) REF CDS984600G, UDI/DI 10195327569679 (each) 40195327569670 (case), Lot Numbers: 24BMC872, 24EMJ590, 24CMJ925, 24EMC239; 45) REF CDS984897K, UDI/DI 10195327313340 (each) 40195327313341 (case), Lot Numbers: 23LBI480, 23ABM802, 23JBM571, 23HBU484, 24BBF370; 46) REF CDS984897L, UDI/DI 10195327621056 (each) 40195327621057 (case), Lot Numbers: 24DBD853; 47) REF CDS984901K, UDI/DI 10193489983838 (each) 40193489983839 (case), Lot Numbers: 22FBH729, 22GBA100, 23EBO954, 23CBE986, 23ABQ723; 48) REF CDS984901L, UDI/DI 10195327448424 (each) 40195327448425 (case), Lot Numbers: 23HBS815, 23IBQ721, 24ABD439, 24BBF371; 49) REF CDS984901M, UDI/DI 10195327620882 (each) 40195327620883 (case), Lot Numbers: 24DBH170; 50) REF CDS984994M, UDI/DI 10195327031091 (each) 40195327031092 (case), Lot Numbers: 22LBJ903, 23ABQ431, 23ABI207, 23HBK190, 23KBH711; 51) REF CDS984994N, UDI/DI 10195327587956 (each) 40195327587957 (case), Lot Numbers: 23LBQ399, 24DBM133; 52) REF CDS985321K, UDI/DI 10195327091477 (each) 40195327091478 (case), Lot Numbers: 22GBB066, 22GBM111, 22FBF378, 23ABC267, 23EBS474, 22JBJ072, 22LBJ973; 53) REF CDS985327I, UDI/DI 10195327091453 (each) 40195327091454 (case), Lot Numbers: 23ABS823, 23ABQ981, 23ABN874; 54) REF CDS985328J, UDI/DI 10195327091286 (each) 40195327091287 (case), Lot Numbers: 22GBF465, 22JBB948, 22IBS703, 23BBG950, 23DBN191, 22KBC287; 55) REF CDS985348F, UDI/DI 10195327243609 (each) 40195327243600 (case), Lot Numbers: 23BDB162, 23ADB379, 22LDA307, 22KDA640, 22JDA443, 23JDC135, 23JDB047, 23LDA591, 24BDA733, 23EDB537, 23DDA312, 24EDA656; 56) REF CDS985422J, UDI/DI 10195327336073 (each) 40195327336074 (case), Lot Numbers: 23DBL260, 23BBJ491, 23EBE971; 57) REF CDS985422K, UDI/DI 10195327418953 (each) 40195327418954 (case), Lot Numbers: 23IBC602, 23GBP490, 23JBO336; 58) REF CDS985426I, UDI/DI 10195327336028 (each) 40195327336029 (case), Lot Numbers: 23BBS373; 59) REF CDS985426J, UDI/DI 10195327450748 (each) 40195327450749 (case), Lot Numbers: 23JBG061, 23HBU188; 60) REF CDS985426K, UDI/DI 10195327527242 (each) 40195327527243 (case), Lot Numbers: 23JBW640; 61) REF CDS985451G, UDI/DI 10195327237639 (each) 40195327237630 (case), Lot Numbers: 23ABA746, 22JBB279, 23EBT937, 23BBJ988; 62) REF CDS985454I, UDI/DI 10195327237646 (each) 40195327237647 (case), Lot Numbers: 22IBV475, 22IBV239, 23EBD643, 22LBD663, 23CBH416, 22LBR599, 23ABL565, 23ABJ391; 63) REF DYNJ00210L, UDI/DI 10193489970586 (each) 40193489970587 (case), Lot Numbers: 22EMG123; 64) REF DYNJ00210M, UDI/DI 10195327259808 (each) 40195327259809 (case), Lot Numbers: 22JMH855, 23BMI151; 65) REF DYNJ00387O, UDI/DI 10193489947137 (each) 40193489947138 (case), Lot Numbers: 22IMF633, 22GMC340, 23AMF222, 23CMF724; 66) REF DYNJ0100957K, UDI/DI 10195327338992 (each) 40195327338993 (case), Lot Numbers: 23EDA745, 23CDC515, 23FDA860; 67) REF DYNJ0101477K, UDI/DI 10195327333089 (each) 40195327333080 (case), Lot Numbers: 23JMI260, 23EMH521, 23IMG325; 68) REF DYNJ0101482I, UDI/DI 10195327295851 (each) 40195327295852 (case), Lot Numbers: 22LMH626; 69) REF DYNJ0101482J, UDI/DI 10195327333003 (each) 40195327333004 (case), Lot Numbers: 23IME981, 23JMJ864; 70) REF DYNJ0105608G, UDI/DI 10889942854158 (each) 40889942854159 (case), Lot Numbers: 23HBA355, 23JBK973, 23LBK459, 23AMH038, 23GBI727; 71) REF DYNJ0161299C, UDI/DI 10195327357276 (each) 40195327357277 (case), Lot Numbers: 23DDB159; 72) REF DYNJ01920N, UDI/DI 10195327491666 (each) 40195327491667 (case), Lot Numbers: 23JBW953, 23IBR209; 73) REF DYNJ02458P, UDI/DI 10195327291105 (each) 40195327291106 (case), Lot Numbers: 23HMC375, 23IMD995; 74) REF DYNJ02575F, UDI/DI 10193489957914 (each) 40193489957915 (case), Lot Numbers: 22HDB947, 23ADA198, 23BDA482; 75) REF DYNJ0271195S, UDI/DI 10195327376048 (each) 40195327376049 (case), Lot Numbers: 23HBJ413, 23FBQ829, 23JBX170; 76) REF DYNJ0311538N, UDI/DI 10889942826612 (each) 40889942826613 (case), Lot Numbers: 22FMF644, 23AMA034; 77) REF DYNJ0366425N, UDI/DI 10195327510671 (each) 40195327510672 (case), Lot Numbers: 23IMF859; 78) REF DYNJ0386381L, UDI/DI 10195327219048 (each) 40195327219049 (case), Lot Numbers: 23CMG152, 22IMA029, 23AMD967; 79) REF DYNJ0426069N, UDI/DI 10195327371319 (each) 40195327371310 (case), Lot Numbers: 23CMH752; 80) REF DYNJ05175M, UDI/DI 10193489520057 (each) 40193489520058 (case), Lot Numbers: 23HBG422, 23LBG736, 23FBS787, 24CBD920; 81) REF DYNJ0519288N, UDI/DI 10195327083960 (each) 40195327083961 (case), Lot Numbers: 22EMH785, 22GMB998, 22FMC229, 22HMB298, 22IMB198, 22LMB065, 23BMC011, 23CMF260; 82) REF DYNJ0531958S, UDI/DI 10195327416072 (each) 40195327416073 (case), Lot Numbers: 23IMC637, 23LMA643, 23FMF208; 83) REF DYNJ0531964X, UDI/DI 10195327416089 (each) 40195327416080 (case), Lot Numbers: 23HMG193, 23HMA324, 23EMI821, 23KMD539, 23JMF450, 23LMF992, 24AMI642, 24CMC880; 84) REF DYNJ0537278AD, UDI/DI 10195327555221 (each) 40195327555222 (case), Lot Numbers: 23LBF288, 24ABT500, 24BBO230, 24DBH900, 24DBA385, 24DBV051; 85) REF DYNJ0589896R, UDI/DI 10195327117948 (each) 40195327117949 (case), Lot Numbers: 22CMI374; 86) REF DYNJ0589896S, UDI/DI 10195327216412 (each) 40195327216413 (case), Lot Numbers: 22HMI264, 22HMB807; 87) REF DYNJ0589896T, UDI/DI 10195327246334 (each) 40195327246335 (case), Lot Numbers: 22KMD334, 23BME504, 22JMC212, 22JMB284; 88) REF DYNJ0589896U, UDI/DI 10195327416102 (each) 40195327416103 (case), Lot Numbers: 23HMA317, 24BMB592, 23JMC542, 23LMA087, 23LMH250, 23EMF424, 24CMA743; 89) REF DYNJ0589896V, UDI/DI 10198459006692 (each) 40198459006693 (case), Lot Numbers: 24FMI167; 90) REF DYNJ0619913K, UDI/DI 10195327239336 (each) 40195327239337 (case), Lot Numbers: 22JMG689; 91) REF DYNJ0619913M, UDI/DI 10195327295882 (each) 40195327295883 (case), Lot Numbers: 22LME112; 92) REF DYNJ0619913N, UDI/DI 10195327333096 (each) 40195327333097 (case), Lot Numbers: 23KMJ075, 23EMB276; 93) REF DYNJ0751401Q, UDI/DI 10195327002749 (each) 40195327002740 (case), Lot Numbers: 22EMB455, 22FME460; 94) REF DYNJ0751401R, UDI/DI 10195327196547 (each) 40195327196548 (case), Lot Numbers: 22IMB088, 22KMD957, 22HMA940; 95) REF DYNJ0751401S, UDI/DI 10195327334185 (each) 40195327334186 (case), Lot Numbers: 23AMH556; 96) REF DYNJ0751444S, UDI/DI 10195327041441 (each) 40195327041442 (case), Lot Numbers: 22EMD332; 97) REF DYNJ0751444T, UDI/DI 10195327196554 (each) 40195327196555 (case), Lot Numbers: 22JMA357, 22LMG204, 22HMA991, 23AMH689, 23DMB327; 98) REF DYNJ0843020L, UDI/DI 10195327286446 (each) 40195327286447 (case), Lot Numbers: 23GDA825, 24CDB634, 23JDA574; 99) REF DYNJ0843063K, UDI/DI 10195327286460 (each) 40195327286461 (case), Lot Numbers: 23JDA179; 100) REF DYNJ0843099I, UDI/DI 10195327286347 (each) 40195327286348 (case), Lot Numbers: 23DDB993, 23DDB128, 23HDC043, 23JDA633; 101) REF DYN... |
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.