MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCO...
FDA Device Recall #Z-0643-2025 — Class II — October 9, 2024
Recall Summary
| Recall Number | Z-0643-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 13057 units |
Product Description
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
85OHD, 1) REF CDS760059I, UDI/DI 10195327009526 (each) 40195327009527 (case), Lot Numbers: 22KBT168, 22GBJ110, 22FBO228, 22FBN206, 23ABM526; 2) REF CDS920099S, UDI/DI 10195327140656 (each) 40195327140657 (case), Lot Numbers: 22EBA153, 23HBS831, 23GBT006, 23ABF835, 23ABE852, 23ABC459, 22IBE827, 22GBP098; 3) REF CDS980998L, UDI/DI 10193489232837 (each) 40193489232838 (case), Lot Numbers: 23HBS764, 24CBA346, 24BBO669; 4) REF CDS982128P, UDI/DI 10195327491659 (each) 40195327491650 (case), Lot Numbers: 23JBV057; 5) REF CDS984262N, UDI/DI 10195327241735 (each) 40195327241736 (case), Lot Numbers: 23ABN752, 23ABH001, 23CBU637, 23EBG216, 23FBL899; 6) REF CDS984900M, UDI/DI 10195327265670 (each) 40195327265671 (case), Lot Numbers: 23EBA735; 7) REF CDS984900N, UDI/DI 10195327448417 (each) 40195327448418 (case), Lot Numbers: 23JBT539, 24ABT539; 8) REF DYNJ0101304G, UDI/DI 10195327351663 (each) 40195327351664 (case), Lot Numbers: 23GDA822, 23CDA336; 9) REF DYNJ0347372J, UDI/DI 10195327555245 (each) 40195327555246 (case), Lot Numbers: 24CBN143, 24DBI923; 10) REF DYNJ17454N, UDI/DI 10195327491604 (each) 40195327491605 (case), Lot Numbers: 23JBR958; 11) REF DYNJ33592I, UDI/DI 10195327469559 (each) 40195327469550 (case), Lot Numbers: 23IDC293; 12) REF DYNJ38844N, UDI/DI 10195327243166 (each) 40195327243167 (case), Lot Numbers: 23DBB947, 23CBN366, 23EBW814, 23BBD619, 23DBI585; 13) REF DYNJ42792D, UDI/DI 10195327653514 (each) 40195327653515 (case), Lot Numbers: 24CBA980; 14) REF DYNJ43770L, UDI/DI 10193489989991 (each) 40193489989992 (case), Lot Numbers: 22IBC524, 22JBT938, 23GBN441, 23KBE916, 23JBJ792, 24ABW049, 24BBJ418, 23DBB305, 22LBI806, 22LBI807, 23ABM291, 23EBT683, 23DBM687, 24CBK840, 24CBA672; 15) REF DYNJ43778L, UDI/DI 10193489990133 (each) 40193489990134 (case), Lot Numbers: 22EBR178, 22DBI437, 22GBK246, 23BBG028, 23FBD832, 23DBB308, 23GBN442, 23LBN691, 24BBK830; 16) REF DYNJ43782K, UDI/DI 10193489989892 (each) 40193489989893 (case), Lot Numbers: 22GBK022, 22JBM498, 22IBD372, 22KBO079, 23JBN680, 23KBK083, 24BBM541, 24ABN836, 24EBE613; 17) REF DYNJ43862J, UDI/DI 10193489990157 (each) 40193489990158 (case), Lot Numbers: 22LLA203, 22JLB142, 22ILA238, 22KLA975, 23ALA636, 23DLA332, 23BLA068, 23FLA225, 23HLA685, 23GLB210, 23KLA370, 23GLA459, 24BLA720, 24ALA170, 23JLA444, 23ILA920, 24DLA220; 18) REF DYNJ44863O, UDI/DI 10195327127619 (each) 40195327127610 (case), Lot Numbers: 22HDB157; 19) REF DYNJ44864S, UDI/DI 10195327127626 (each) 40195327127627 (case), Lot Numbers: 22GBA089, 23DBR620, 22HBY159, 22EBC670, 23BBV092; 20) REF DYNJ44876L, UDI/DI 10195327127695 (each) 40195327127696 (case), Lot Numbers: 22HDB217; 21) REF DYNJ44876M, UDI/DI 10195327298418 (each) 40195327298419 (case), Lot Numbers: 22LDB769, 23CDA215, 23CDA612; 22) REF DYNJ45184F, UDI/DI 10195327191474 (each) 40195327191475 (case), Lot Numbers: 22FBW406, 22JBD483, 23BBK976, 23CBT915; 23) REF DYNJ47766Q, UDI/DI 10195327270001 (each) 40195327270002 (case), Lot Numbers: 23GDA728; 24) REF DYNJ48638G, UDI/DI 10195327109158 (each) 40195327109159 (case), Lot Numbers: 22DBQ919, 23DBB019, 23CBH108, 23ABL241, 23GBM672; 25) REF DYNJ52397M, UDI/DI 10195327339098 (each) 40195327339099 (case), Lot Numbers: 23EDC260; 26) REF DYNJ52524C, UDI/DI 10889942796915 (each) 40889942796916 (case), Lot Numbers: 23CMF377; 27) REF DYNJ53650D, UDI/DI 10195327337643 (each) 40195327337644 (case), Lot Numbers: 23GBT276, 23IBU040, 24ABC282, 24BBH893, 23FBR552, 23IBA185; 28) REF DYNJ59079D, UDI/DI 10195327200251 (each) 40195327200252 (case), Lot Numbers: 22LBL494, 22GBY139, 23ABL800, 23ABB585, 23CBV720, 23JBT579, 23IBM532; 29) REF DYNJ62107B, UDI/DI 10195327350895 (each) 40195327350896 (case), Lot Numbers: 23FBE253; 30) REF DYNJ63326D, UDI/DI 10195327094409 (each) 40195327094400 (case), Lot Numbers: 22JMC433, 22JMC435, 22DBM777; 31) REF DYNJ63606C, UDI/DI 10193489900248 (each) 40193489900249 (case), Lot Numbers: 22FBV006, 23BBC458, 23FBF843, 23JBP024; 32) REF DYNJ64234B, UDI/DI 10193489382655 (each) 40193489382656 (case), Lot Numbers: 22GMB743, 22LMF980; 33) REF DYNJ64793A, UDI/DI 10193489457391 (each) 40193489457392 (case), Lot Numbers: 22GDA994; 34) REF DYNJ64793B, UDI/DI 10195327217914 (each) 40195327217915 (case), Lot Numbers: 23IDA919, 23LDB556, 23ADB401, 22KDB707, 23CDC139, 23CDA142; 35) REF DYNJ64793C, UDI/DI 10195327639075 (each) 40195327639076 (case), Lot Numbers: 24CDA102; 36) REF DYNJ65373A, UDI/DI 10195327417987 (each) 40195327417988 (case), Lot Numbers: 23FMD177; 37) REF DYNJ67190C, UDI/DI 10195327304201 (each) 40195327304202 (case), Lot Numbers: 23BBC622, 22LBO811, 23BBM118, 23DBK217; 38) REF DYNJ68563A, UDI/DI 10193489994841 (each) 40193489994842 (case), Lot Numbers: 23GBW287; 39) REF DYNJ68563B, UDI/DI 10195327511791 (each) 40195327511792 (case), Lot Numbers: 24ABC442, 24ABP074; 40) REF DYNJ69169A, UDI/DI 10195327156480 (each) 40195327156481 (case), Lot Numbers: 23AME723, 23AMA205; 41) REF DYNJ69490C, UDI/DI 10195327243913 (each) 40195327243914 (case), Lot Numbers: 23GDA238; 42) REF DYNJ84776A, UDI/DI 10195327615987 (each) 40195327615988 (case), Lot Numbers: 24DME593, 24BMG248, 24BMB085, 24CMC391, 24CMK067; 43) REF DYNJ901281G, UDI/DI 10195327349066 (each) 40195327349067 (case), Lot Numbers: 23GBU141; 44) REF DYNJ901282J, UDI/DI 10195327349202 (each) 40195327349203 (case), Lot Numbers: 23GBF221, 23GBF801, 23JBU677; 45) REF DYNJ902498J, UDI/DI 10195327336424 (each) 40195327336425 (case), Lot Numbers: 23GBJ197, 23FBK861; 46) REF DYNJ902583M, UDI/DI 10195327600952 (each) 40195327600953 (case), Lot Numbers: 24BBU793; 47) REF DYNJ902953G, UDI/DI 10195327118075 (each) 40195327118076 (case), Lot Numbers: 22HMA128; 48) REF DYNJ902953I, UDI/DI 10195327216597 (each) 40195327216598 (case), Lot Numbers: 22JMC312; 49) REF DYNJ902953J, UDI/DI 10195327296254 (each) 40195327296255 (case), Lot Numbers: 22LMA416, 23AMA855, 23CMB170; 50) REF DYNJ902953K, UDI/DI 10195327488710 (each) 40195327488711 (case), Lot Numbers: 23HMG988, 24AMA644, 23LMA536, 23IMD748, 24DMK165, 24CMH773, 24BMF820, 23IMD761, 24EMG520, 24EMB536, 24FMJ241; 51) REF DYNJ903459F, UDI/DI 10195327200374 (each) 40195327200375 (case), Lot Numbers: 22KBR937, 23EBG039, 23BBK004, 23FBT549, 23HBV186, 23IBC012; 52) REF DYNJ903539G, UDI/DI 10195327425524 (each) 40195327425525 (case), Lot Numbers: 23GMB348; 53) REF DYNJ904490I, UDI/DI 10195327186326 (each) 40195327186327 (case), Lot Numbers: 23ABJ533; 54) REF DYNJ904792C, UDI/DI 10195327072803 (each) 40195327072804 (case), Lot Numbers: 23HDC090, 23CDB391; 55) REF DYNJ904793B, UDI/DI 10195327072650 (each) 40195327072651 (case), Lot Numbers: 22GDA529, 23GDB165, 23HDA865, 23JDC274; 56) REF DYNJ906112B, UDI/DI 10195327597375 (each) 40195327597376 (case), Lot Numbers: 24BBH136, 24DBT158, 24DBV357; 57) REF DYNJ906445A, UDI/DI 10195327167288 (each) 40195327167289 (case), Lot Numbers: 22GBJ176; 58) REF DYNJ906445B, UDI/DI 10195327228392 (each) 40195327228393 (case), Lot Numbers: 23EBT765, 23EBF127; 59) REF DYNJ906445C, UDI/DI 10195327436414 (each) 40195327436415 (case), Lot Numbers: 23JBM489, 23HBV246, 23JBW647, 24BBK908, 24BBQ096, 24DBL767; 60) REF DYNJ907153C, UDI/DI 10195327600778 (each) 40195327600779 (case), Lot Numbers: 24GBT128, 24EBE754; 61) REF DYNJ907392A, UDI/DI 10195327329525 (each) 40195327329526 (case), Lot Numbers: 23CMA009, 23FMI177, 23CMB744, 23GMC935; 62) REF DYNJ907392B, UDI/DI 10195327462338 (each) 40195327462339 (case), Lot Numbers: 23JMC266; 63) REF DYNJ907396B, UDI/DI 10195327329532 (each) 40195327329533 (case), Lot Numbers: 23DMA650, 23BME717, 23BME738, 23GMC937, 23FMC911, 23GMH664, 23FMA674; 64) REF DYNJ907396C, UDI/DI 10195327462352 (each) 40195327462353 (case), Lot Numbers: 23IMF381, 23JME981; 65) REF DYNJ907407A, UDI/DI 10195327335809 (each) 40195327335800 (case), Lot Numbers: 23EME041; 66) REF DYNJ907407B, UDI/DI 10195327462208 (each) 40195327462209 (case), Lot Numbers: 23HMF546; 67) REF DYNJ907910, UDI/DI 10193489941807 (each) 40193489941808 (case), Lot Numbers: 22EBI105, 22IBM319, 22EBG580, 22EBE690, 22EBF759; 68) REF DYNJ907910A, UDI/DI 10195327225155 (each) 40195327225156 (case), Lot Numbers: 23CBN033, 22KBT244; 69) REF DYNJ908783, UDI/DI 10195327183301 (each) 40195327183302 (case), Lot Numbers: 23CDB746, 23FDB402, 23DDC292, 23HDC431; 70) REF DYNJ908783A, UDI/DI 10195327520267 (each) 40195327520268 (case), Lot Numbers: 23KMF011, 23LMC664; 71) REF DYNJ909398A, UDI/DI 10195327338190 (each) 40195327338191 (case), Lot Numbers: 23HME512, 23KME175, 23JMB528, 23HMI269, 24EMC327, 24HMG886; 72) REF DYNJ910084, UDI/DI 10195327568993 (each) 40195327568994 (case), Lot Numbers: 24ABI431, 23LBT816, 24EBD996; 73) REF DYNJ910125, UDI/DI 10195327594930 (each) 40195327594931 (case), Lot Numbers: 24DBF506
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.