Refer to RES or lead review memo for complete list of affected reference/catalog numbers — FDA record Z-0635-2025

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
Refer to RES or lead review memo for complete list of affected reference/catalog numbers
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
102561 units
Agency-reported status
Ongoing
Source record identifier
Z-0635-2025

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 applicability1) REF CDS780147M, UDI/DI 10193489445510 (each) 40193489445511 (case), Lot Numbers: 22EBM611, 22EBO511; 2) REF CDS860040K, UDI/DI 10195327010447 (each) 40195327010448 (case), Lot Numbers: 22ELA276, 23ALB139, 23ELA269, 23CLB184, 22JLA300; 3) REF CDS980245X, UDI/DI 10193489848434 (each) 40193489848435 (case), Lot Numbers: 22GBS312, 22FBG764, 22KBJ856, 23BBG738; 4) REF CDS980566F, UDI/DI 10193489445442 (each) 40193489445443 (case), Lot Numbers: 22HBJ660, 22GBE251, 22JBF110, 22KBE727, 23ABL563, 23DBD997, 23BBG522, 23GBF733; 5) REF CDS982933N, UDI/DI 10193489879117 (each) 40193489879118 (case), Lot Numbers: 22FBG572, 22JBQ100; 6) REF CDS982936U, UDI/DI 10195327185220 (each) 40195327185221 (case), Lot Numbers: 23ABF691; 7) REF CDS983293F, UDI/DI 10193489590616 (each) 40193489590617 (case), Lot Numbers: 22GBY030; 8) REF CDS983467J, UDI/DI 10195327561116 (each) 40195327561117 (case), Lot Numbers: 24ADC216, 24ADA818, 24BDA929, 24EDA751; 9) REF CDS983470I, UDI/DI 10195327561154 (each) 40195327561155 (case), Lot Numbers: 23LDA393, 24ADC171; 10) REF CDS983477K, UDI/DI 10195327560867 (each) 40195327560868 (case), Lot Numbers: 24ADA523, 24EDA272; 11) REF CDS983479O, UDI/DI 10195327497446 (each) 40195327497447 (case), Lot Numbers: 23KDA634, 23LDB753, 24BDB695; 12) REF CDS983488K, UDI/DI 10195327561147 (each) 40195327561148 (case), Lot Numbers: 24ADA074, 24EDA221; 13) REF CDS983494K, UDI/DI 10195327561123 (each) 40195327561124 (case), Lot Numbers: 23LDB243, 24BDB988; 14) REF CDS983908O, UDI/DI 10193489402773 (each) 40193489402774 (case), Lot Numbers: 22GBT396; 15) REF CDS983914K, UDI/DI 10193489402698 (each) 40193489402699 (case), Lot Numbers: 22EBA061, 22DBU743, 22GBI220; 16) REF CDS984599F, UDI/DI 10193489486148 (each) 40193489486149 (case), Lot Numbers: 22EMH743, 22HMA205, 22GMB332, 22KMF120, 22KMF139, 22HMF967, 23FME358, 23AMI307, 22LMF801, 23GMB934, 23KMF368, 23LMC668; 17) REF CDS984600F, UDI/DI 10193489486100 (each) 40193489486101 (case), Lot Numbers: 22JME533, 22HMH038, 23FMA360, 23EMI198, 23AMJ617, 23AMG705, 22LMI741, 23KMJ525, 23JMK211; 18) REF CDS984640G, UDI/DI 10195327435806 (each) 40195327435807 (case), Lot Numbers: 23IBD455, 23FBU659, 23JBF568, 23JBS933; 19) REF CDS984897J, UDI/DI 10193489983845 (each) 40193489983846 (case), Lot Numbers: 22KBM268; 20) REF CV6222T, UDI/DI 10193489314625 (each) 40193489314626 (case), Lot Numbers: 22ILA422, 23ILA216, 24ALA281, 23FLA764, 23DLA119; 21) REF DYNJ0101232F, UDI/DI 10195327028862 (each) 40195327028863 (case), Lot Numbers: 23DMI192, 23JBC628; 22) REF DYNJ0101285F, UDI/DI 10195327286569 (each) 40195327286560 (case), Lot Numbers: 23JDA016; 23) REF DYNJ0101339K, UDI/DI 10195327286583 (each) 40195327286584 (case), Lot Numbers: 23FDC341, 23EDC145, 23DDB460; 24) REF DYNJ0101435I, UDI/DI 10195327239473 (each) 40195327239474 (case), Lot Numbers: 23HMC631; 25) REF DYNJ0105614I, UDI/DI 10889942854165 (each) 40889942854166 (case), Lot Numbers: 23GBI709; 26) REF DYNJ0113967O, UDI/DI 10889942854189 (each) 40889942854180 (case), Lot Numbers: 23HBE512, 24ABO593; 27) REF DYNJ0161854D, UDI/DI 10195327304324 (each) 40195327304325 (case), Lot Numbers: 23DDB024, 23BDA412; 28) REF DYNJ0161949C, UDI/DI 10195327304331 (each) 40195327304332 (case), Lot Numbers: 22LDA230; 29) REF DYNJ01928K, UDI/DI 10195327491574 (each) 40195327491575 (case), Lot Numbers: 23KBI399; 30) REF DYNJ0259893T, UDI/DI 10195327356750 (each) 40195327356751 (case), Lot Numbers: 23DMA326; 31) REF DYNJ0282079U, UDI/DI 10195327589394 (each) 40195327589395 (case), Lot Numbers: 24ABX980, 24ABH203, 24DBV818, 24CBT374; 32) REF DYNJ0325443N, UDI/DI 10195327376055 (each) 40195327376056 (case), Lot Numbers: 23KBD218, 23GBI710; 33) REF DYNJ0378367R, UDI/DI 10195327494926 (each) 40195327494927 (case), Lot Numbers: 23JBD244, 23KBD947; 34) REF DYNJ0378388Q, UDI/DI 10195327500665 (each) 40195327500666 (case), Lot Numbers: 23JBV566; 35) REF DYNJ0426069L, UDI/DI 10195327058029 (each) 40195327058020 (case), Lot Numbers: 22ELB112, 22EMI117; 36) REF DYNJ0426069M, UDI/DI 10195327205751 (each) 40195327205752 (case), Lot Numbers: 23AMH835, 22KME294, 23BMH216; 37) REF DYNJ0451468O, UDI/DI 10195327133993 (each) 40195327133994 (case), Lot Numbers: 22FBS258, 22EBH139, 22IBG605, 22KBD097, 23FBL656, 23BBH595, 23HBA302, 23CBB976, 23GBI183, 23CBP369, 23JBX426; 38) REF DYNJ0488631K, UDI/DI 10195327045951 (each) 40195327045952 (case), Lot Numbers: 22EBS985; 39) REF DYNJ0488631L, UDI/DI 10195327268831 (each) 40195327268832 (case), Lot Numbers: 22LBK638, 23CBM512, 23GBO248, 23IBS187, 23KBA400; 40) REF DYNJ0506906S, UDI/DI 10195327356774 (each) 40195327356775 (case), Lot Numbers: 23CMH763; 41) REF DYNJ0516935J, UDI/DI 10195327049720 (each) 40195327049721 (case), Lot Numbers: 22FMA111, 22LMF274; 42) REF DYNJ0516935K, UDI/DI 10195327376864 (each) 40195327376865 (case), Lot Numbers: 23DME703, 23HMI006; 43) REF DYNJ0519294K, UDI/DI 10195327084851 (each) 40195327084852 (case), Lot Numbers: 22FMG362, 22GMC619, 22FMF113, 22EMG243, 22HMG065, 22LMA637, 23CMA602, 23DMB986; 44) REF DYNJ0531958Q, UDI/DI 10195327124670 (each) 40195327124671 (case), Lot Numbers: 22GMH926; 45) REF DYNJ0531958R, UDI/DI 10195327248048 (each) 40195327248049 (case), Lot Numbers: 22JMB533, 23CMB334; 46) REF DYNJ0531958T, UDI/DI 10198459006685 (each) 40198459006686 (case), Lot Numbers: 24FMJ982; 47) REF DYNJ0531964U, UDI/DI 10195327124762 (each) 40195327124763 (case), Lot Numbers: 22EMD975, 22EMA812; 48) REF DYNJ0531964V, UDI/DI 10195327216634 (each) 40195327216635 (case), Lot Numbers: 22HMG182, 22HMB122; 49) REF DYNJ0531964W, UDI/DI 10195327247966 (each) 40195327247967 (case), Lot Numbers: 22IMF603, 23BMB839, 23AMG569, 22KMB504, 23AMJ168, 23CMF261; 50) REF DYNJ0531985Q, UDI/DI 10195327118051 (each) 40195327118052 (case), Lot Numbers: 22GMC357, 22EME756; 51) REF DYNJ0531985S, UDI/DI 10195327416096 (each) 40195327416097 (case), Lot Numbers: 23LMD355, 23FMD700, 23JMH216, 23IMC636, 24DMF603, 24CMA090, 24BME181, 24AMI796, 23KMJ723, 24FMJ024, 24EMF038; 52) REF DYNJ0537263Y, UDI/DI 10195327556327 (each) 40195327556328 (case), Lot Numbers: 24ABK840, 24BBA963, 24CBN144, 24DBB242, 24DBA384; 53) REF DYNJ0537337X, UDI/DI 10195327268183 (each) 40195327268184 (case), Lot Numbers: 23CMD577, 23AMG264, 22JMF188; 54) REF DYNJ0537337Y, UDI/DI 10195327418502 (each) 40195327418503 (case), Lot Numbers: 23FMA114; 55) REF DYNJ0553564U, UDI/DI 10195327599706 (each) 40195327599707 (case), Lot Numbers: 24ABO538, 24DBG803; 56) REF DYNJ0774133L, UDI/DI 10195327130169 (each) 40195327130160 (case), Lot Numbers: 22EMA817, 22GMF253; 57) REF DYNJ0774133N, UDI/DI 10195327246167 (each) 40195327246168 (case), Lot Numbers: 22JMC088; 58) REF DYNJ0826572K, UDI/DI 10193489265392 (each) 40193489265393 (case), Lot Numbers: 22EMB124, 23HMH778, 23HME726, 23JMF421; 59) REF DYNJ0826667P, UDI/DI 10193489265705 (each) 40193489265706 (case), Lot Numbers: 23AMF857, 23IMD334; 60) REF DYNJ0826673M, UDI/DI 10193489266948 (each) 40193489266949 (case), Lot Numbers: 23AMC209, 23DME467, 23IMD335, 23JMH642; 61) REF DYNJ0843339O, UDI/DI 10195327567057 (each) 40195327567058 (case), Lot Numbers: 24CDB480; 62) REF DYNJ0854719M, UDI/DI 10195327649548 (each) 40195327649549 (case), Lot Numbers: 24CMA981; 63) REF DYNJ14004N, UDI/DI 10193489873887 (each) 40193489873888 (case), Lot Numbers: 22IBH386, 22HBE549, 22GBB385, 22EBN664, 22JBI056, 23ABO098, 22LBD898, 23BBN052, 23CBS525, 23DBR760; 64) REF DYNJ20866F, UDI/DI 10195327658113 (each) 40195327658114 (case), Lot Numbers: 24DBS469; 65) REF DYNJ21408D, UDI/DI 10195327053642 (each) 40195327053643 (case), Lot Numbers: 22LBG764, 23FBJ835, 23IBM377, 23KBE049; 66) REF DYNJ24336I, UDI/DI 10195327653163 (each) 40195327653164 (case), Lot Numbers: 24CBS604, 24EBB420; 67) REF DYNJ24341J, UDI/DI 10195327597313 (each) 40195327597314 (case), Lot Numbers: 24ABY372, 24EBH312, 24ABY511; 68) REF DYNJ24342K, UDI/DI 10195327597344 (each) 40195327597345 (case), Lot Numbers: 24ABA081, 24BBN689, 24EBT045; 69) REF DYNJ24343J, UDI/DI 10195327597368 (each) 40195327597369 (case), Lot Numbers: 24ABY519, 24DBC222; 70) REF DYNJ24344K, UDI/DI 10195327601850 (each) 40195327601851 (case), Lot Numbers: 24CBH092; 71) REF DYNJ24365I, UDI/DI 10195327603977 (each) 40195327603978 (case), Lot Numbers: 24BBF417, 24ABX190, 24CBT994; 72) REF DYNJ24372F, UDI/DI 10195327667351 (each) 40195327667352 (case), Lot Numbers: 24DBC974, 24DBT693; 73) REF DYNJ24375F, UDI/DI 10195327667368 (each) 40195327667369 (case), Lot Numbers: 24CBQ529; 74) REF DYNJ24449S, UDI/DI 10195327658144 (each) 40195327658145 (case), Lot Numbers: 24CBQ519, 24EBE127, 20LBP965; 75) REF DYNJ25504D, UDI/DI 10195327658120 (each) 40195327658121 (case), Lot Numbers: 24CBI561, 24EBF344; 76) REF DYNJ30425F, UDI/DI 10195327076955 (each) 40195327076956 (case), Lot Numbers: 22FBA342, 22GBA368; 77) REF DYNJ33749C, UDI/DI 10195327350994 (each) 40195327350995 (case), Lot Numbers: 23EBO841, 23HBQ651, 23CBE236, 23JBB469, 23IBJ652, 23JBQ933; 78) REF DYNJ34816F, UDI/DI 10195327060626 (each) 40195327060627 (case), Lot Numbers: 22EBU948, 22JBV712, 23IBI796, 22LBE420, 24BBC205, 23GBJ148; 79) REF DYNJ34979B, UDI/DI 10193489733006 (each) 40193489733007 (case), Lot Numbers: 23BMH696, 23FMB875; 80) REF DYNJ36096D, UDI/DI 10195327080259 (each) 40195327080250 (case), Lot Numbers: 22GMG094; 81) REF DYNJ37615J, UDI/DI 10195327560881 (each) 40195327560882 (case), Lot Numbers: 24ADA531, 24CDA966, 24CDA744; 82) REF DYNJ40617D, UDI/DI 10193489699678 (each) 40193489699679 (case), Lot Numbers: 22EBP815, 22GBG154, 22HBC406, 22LBL216, 23CBV863, 23FBD200; 83) REF DYNJ40618C, UDI/DI 10193489699685 (each) 40193489699686 (case), Lot Numbers: 22FBA977, 22EBG744, 22DBO554, 22KBF165, 23ABM212, 23CBM026, 23EBT507, 23CBV138; 84) REF DYNJ40624D, UDI/DI 10193489699708 (each) 40193489699709 (case), Lot Numbers: 23CBI385, 22KBH593, 23EBT509; 85) REF DYNJ40626F, UDI/DI 10193489699715 (each) 40193489699716 (case), Lot Numbers: 22DBS697, 22KBC526, 23BBQ136, 23EBT510; 86) REF DYNJ41209D, UDI/DI 10195327338688 (each) 40195327338689 (case), Lot Numbers: 23GMI187, 23IME005, 23JMG325; 87) REF DYNJ42791F, UDI/DI 10193489827538 (each) 40193489827539 (case), Lot Numbers: 22GMH168, 22DMF767, 22FMF032, 23BME491, 22IMC331, 23AMB210, 22KMC254, 23BME490; 88) REF DYNJ42792C, UDI/DI 10193489425307 (each) 40193489425308 (case), Lot Numbers: 23BMG569, 22HMH739, 23EMG053, 23JBX377, 23KBT332, 23KBH495, 23GBJ291; 89) REF DYNJ43227I, UDI/DI 10193489953046 (each) 40193489953047 (case), Lot Numbers: 22LMB115, 23CME917; 90) REF DYNJ43486D, UDI/DI 10195327600631 (each) 40195327600632 (case), Lot Numbers: 24ABG165, 24BBM191, 24CBS613, 24EBA896; 91) REF DYNJ43774I, UDI/DI 10193489990003 (each) 40193489990004 (case), Lot Numbers: 22FBD559, 22LBJ470, 23HBS627, 23DBM688, 22JBQ881, 23HBC081, 23DBB307, 23JBD686, 23KBO974, 24BBK332, 24DBQ210; 92) REF DYNJ44051C, UDI/DI 10195327200558 (each) 40195327200559 (case), Lot Numbers: 22KLB112, 22LLA388, 23ELB226, 23ELA448, 23DLA265, 23ALA929, 23GLA640; 93) REF DYNJ44158I, UDI/DI 10195327412890 (each) 40195327412891 (case), Lot Numbers: 23IBB796, 23GBW355, 23FBL375; 94) REF DYNJ44858J, UDI/DI 10195327127336 (each) 40195327127337 (case), Lot Numbers: 22GBF622, 22EBQ172, 22DBV040, 22JBT781, 23ABJ467, 22LBK475, 23CBJ170; 95) REF DYNJ44865G, UDI/DI 10195327127633 (each) 40195327127634 (case), Lot Numbers: 22HBD774, 22EBG859; 96) REF DYNJ44866P, UDI/DI 10195327127640 (each) 40195327127641 (case), Lot Numbers: 23ADB797, 22EDB864, 23ADA255, 22LDB754, 23BDC058; 97) REF DYNJ44899R, UDI/DI 10195327127763 (each) 40195327127764 (case), Lot Numbers: 22HMC231, 23AMI994; 98) REF DYNJ45576C, UDI/DI 10195327683870 (each) 40195327683871 (case), Lot Numbers: 24DBQ041; 99) REF DYNJ46380P, UDI/DI 10195327553470 (each) 40195327553471 (case), Lot Numbers: 23KMF776; 100) REF DYNJ47131F, UDI/DI 10195327104481 (each) 40195327104482 (case), Lot Numbers: 22EBV562, 23DBI589, 23CBO697, 23ABL411; 101) REF DYNJ48131K, UDI/DI 10195327349455 (each) 40195327349456 (case), Lot Numbers: 23CBS766; 102) REF DYNJ49229F, UDI/DI 10...

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.

Related records