--- title: "Refer to RES or lead review memo for complete list of affected reference/cata... — FDA record Z-0635-2025 | Is It on Recall" description: "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker." url: https://isitonrecall.com/recall/fda-device-z-0635-2025-refer-to-res-or-lead-review-memo-for-complete-list-of-affected-reference-catalog-numbers/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0635-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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 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](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0635-2025%22). 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](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0635-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [MEDLINE INDUSTRIES, LP - Northfield records](https://isitonrecall.com/brand/medline-industries-lp-northfield/)