MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, R...
FDA Device Recall #Z-0526-2026 — Class II — September 30, 2025
Recall Summary
| Recall Number | Z-0526-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 30, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 11032 kits |
Product Description
MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C.
Reason for Recall
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23JBR313; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 23KBB240; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24DBA895; REF CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case), Lot Numbers: 24EBI651; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23FBP399; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23HBP624; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23IBE037; REF CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case), Lot Numbers: 23JBC747; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 23LBM204; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24ABL069; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24CBM113; REF CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case), Lot Numbers: 24FBE246; REF DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case), Lot Numbers: 23EDA073; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23GBP147; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBD395; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 23HBP685; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24BBV536; REF DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case), Lot Numbers: 24EBF239; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23HMD981; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 23KBF163; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBH765; REF DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case), Lot Numbers: 24BBT798; REF DYNJ0551409P, UDI/DI: 10195327561871 (each) 40195327561872 (case), Lot Numbers: 24BBC833; REF DYNJ07836R, UDI/DI: 10195327349431 (each) 40195327349432 (case), Lot Numbers: 24BBH764; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 23LBC980; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABQ944; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABR003; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24ABV987; REF DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case), Lot Numbers: 24BBG949; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23GMF903; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23HMF589; REF DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case), Lot Numbers: 23JMB497; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23EBO244; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23FBR011; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBD673; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23HBH801; REF DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case), Lot Numbers: 23IBP528; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMF816; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23DMI790; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23EMG135; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23FMI968; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23GMI116; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23HMA195; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 23JMC837; REF DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case), Lot Numbers: 24BMB829; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23DMI785; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23EMJ326; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23GMD537; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23IMF534; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 23KMB242; REF DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case), Lot Numbers: 24BMC270; REF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23HBQ392; REF DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case), Lot Numbers: 23LBT819; REF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24CBM675; REF DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case), Lot Numbers: 24EBP120; REF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBK092; REF DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case), Lot Numbers: 23EBS759; REF DYNJ47808F, UDI/DI: 10195327232603 (each) 40195327232604 (case), Lot Numbers: 23GMI543; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24ABE884; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24BBI603; REF DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case), Lot Numbers: 24CBU107; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23JME469; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 23KMH696; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24DMD663; REF DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case), Lot Numbers: 24KMD766; REF DYNJ52481B, UDI/DI: 10195327689773 (each) 40195327689774 (case), Lot Numbers: 24DBO831; REF DYNJ59457B, UDI/DI: 10195327446574 (each) 40195327446575 (case), Lot Numbers: 23KMD078; REF DYNJ59825A, UDI/DI: 10195327331610 (each) 40195327331611 (case), Lot Numbers: 23HLA627; REF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBD197; REF DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case), Lot Numbers: 23EBR612; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23EBB409; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23GBG734; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23HBM866; REF DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case), Lot Numbers: 23IBR809; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 23HBI631; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24ABI243; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24BBC533; REF DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case), Lot Numbers: 24DBO874; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23EDC402; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23FDC227; REF DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case), Lot Numbers: 23HDB277; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23IMG148; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23JME325; REF DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case), Lot Numbers: 23LMA555; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24AMF996; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24BMI121; REF DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case), Lot Numbers: 24CMF007; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23KMI521; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 23LMF119; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24AMC075; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24CMI550; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24EMH988; REF DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case), Lot Numbers: 24FME482; REF DYNJ65403A, UDI/DI: 10193489417081 (each) 40193489417082 (case), Lot Numbers: 24ABS258; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23EBO612; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23HBR353; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23IBJ604; REF DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case), Lot Numbers: 23KBD084; REF DYNJ69445, UDI/DI: 10193489942514 (each) 40193489942515 (case), Lot Numbers: 23GBA532; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 23KBU661; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBH876; REF DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case), Lot Numbers: 24BBI439; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23DBJ057; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23EBN921; REF DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case), Lot Numbers: 23FBB765; REF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23GBK114; REF DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case), Lot Numbers: 23JBK156; REF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23EBM401; REF DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case), Lot Numbers: 23IBQ454; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23HBW089; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23IBK153; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBU485; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 23LBV117; REF DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case), Lot Numbers: 24DBR994; REF DYNJ83980, UDI/DI: 10195327323554 (each) 40195327323555 (case), Lot Numbers: 24ABR096; REF DYNJ85612, UDI/DI: 10195327523770 (each) 40195327523771 (case), Lot Numbers: 23LMF612; REF DYNJ85770, UDI/DI: 10195327546557 (each) 40195327546558 (case), Lot Numbers: 24AMG054; REF DYNJ86173, UDI/DI: 10195327609412 (each) 40195327609413 (case), Lot Numbers: 24CBA422; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBG515; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 23LBQ424; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABG727; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABS178; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24ABW963; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24BBQ451; REF DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case), Lot Numbers: 24CBT653; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23KMD690; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 23LMG846; REF DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case), Lot Numbers: 24AMG510; REF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 23LMC684; REF DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case), Lot Numbers: 24AMA761; REF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24CMH459; REF DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case), Lot Numbers: 24GMH592; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23HBH779; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23IBP238; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23JBS995; REF DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case), Lot Numbers: 23KBM075; REF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23EDB517; REF DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case), Lot Numbers: 23FDB192; REF DYNJ906263D, UDI/DI: 10195327344375 (each) 40195327344376 (case), Lot Numbers: 23HBJ335; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23HMD044; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23JMH952; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 23KMF087; REF DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case), Lot Numbers: 24AMB283; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23GMI390; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23KMJ296; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 23LMH787; REF DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case), Lot Numbers: 24BMJ492; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24DMG311; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24FMB530; REF DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case), Lot Numbers: 24HMJ414; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23JMF237; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 23KMG863; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24AMI231; REF DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case), Lot Numbers: 24HMD222; REF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23GDB702; REF PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case), Lot Numbers: 23HDA942.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1650-2026 | Class II | Puracol and Puracol Plus Collagen Wound Dressin... | Feb 10, 2026 |
| Z-1562-2026 | Class II | Medline Kits containing Cardinal Health s Aqua-... | Jan 30, 2026 |
| Z-1563-2026 | Class II | Medline Medcrest Surgical Gowns: MDTGXC4J5XL... | Jan 28, 2026 |
| Z-1564-2026 | Class II | Medline Surgical Drapes: MDTBTCS6070GN DBD-DRA... | Jan 28, 2026 |
| Z-1464-2026 | Class II | Medline Kits containing Tego Connectors Medlin... | Jan 8, 2026 |
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.