Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CO...
FDA Device Recall #Z-1413-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1413-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 7, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 7494 units |
Product Description
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 15) NEURO PACK, Model Number: DYNJ49098I; 16) NEURO PACK, Model Number: DYNJ53089B; 17) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 18) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 19) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 20) NEURO PACK, Model Number: DYNJ60792B; 21) NEURO PACK, Model Number: DYNJ60792C; 22) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 24) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 25) NEURO PACK, Model Number: DYNJ61740D; 26) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 27) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 28) DISCECTOMY PACK, Model Number: DYNJ67835; 29) WWD NEURO PACK, Model Number: DYNJ80849B; 30) WWD NEURO PACK, Model Number: DYNJ80849J; 31) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 32) NEURO, Model Number: DYNJ900904J; 33) NEURO, Model Number: DYNJ900904K; 34) NEURO, Model Number: DYNJ900904L; 35) NEURO, Model Number: DYNJ900904M; 36) NEURO, Model Number: DYNJ902585; 37) NEURO, Model Number: DYNJ902585A; 38) NEURO - IFCAP 230316, Model Number: DYNJ908393; 39) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 40) NEURO KIT, Model Number: DYNJ909573; 41) NEURO, Model Number: DYNJ910384; 42) NEURO, Model Number: DYNJ910384A; 43) NEURO PACK-LF, Model Number: PHS390015M
Reason for Recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distribution Pattern
Worldwide distribution - US Nationwide.
Lot / Code Information
1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24EMI161; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 24CMA817; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23KMB758; 18) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMI786; 19) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23JMA572; 20) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23IME897; 21) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 22) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 23) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22OBC508; 24) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22NBA962; 25) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22IBE871; 26) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBF303; 27) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22FBC967; 28) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBO542; 29) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22EBA074; 30) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22DBD203; 31) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 22BBT015; 32) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21LBL164; 33) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21JBB951; 34) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21HBN643; 35) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBS468; 36) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21GBG761; 37) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21FBE311; 38) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21DBE120; 39) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBP552; 40) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21BBA521; 41) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABU817; 42) DYKMBNDL138, UDI-DI: 10193489478150(each), 40193489478151(case), Lot Number: 21ABL131; 43) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBG852; 44) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21BBB221; 45) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABW870; 46) DYKMBNDL142, UDI-DI: 10193489478198(each), 40193489478199(case), Lot Number: 21ABL138; 47) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24LBI083; 48) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBK044; 49) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24KBA532; 50) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24JBS893; 51) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24GBS072; 52) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24EBQ164; 53) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24DBJ890; 54) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBU410; 55) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24CBA173; 56) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 24ABL221; 57) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23KBK072; 58) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23IBS183; 59) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23HBT876; 60) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23GBE625; 61) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23FBE493; 62) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23DBF392; 63) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBP083; 64) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23CBG764; 65) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23BBU041; 66) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 23ABU154; 67) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22LBR466; 68) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22KBB452; 69) DYKMBNDL142B, UDI-DI: 10195327240707(each), 40195327240708(case), Lot Number: 22IBN422; 70) DYKMBNDL145, UDI-DI: 10193489478365(each), 40193489478366(case), Lot Number: 21ABT643; 71) DYKMBNDL145B, UDI-DI: 10195327240776(each), 40195327240777(case), Lot Number: 24HBF314; 72) DYKMBNDL5, UDI-DI: 10193489477634(each), 40193489477635(case), Lot Number: 21ABQ194; 73) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25KBQ729; 74) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25FBD172; 75) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25DBO558; 76) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 25BBM404; 77) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBJ842; 78) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24LBH040; 79) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24GBK951; 80) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24EBC897; 81) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24DBJ607; 82) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 24BBG003; 83) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23LBL844; 84) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23FBP269; 85) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23EBB597; 86) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 23ABK051; 87) DYKMBNDL5B, UDI-DI: 10195327241100(each), 40195327241101(case), Lot Number: 22IBJ928; 88) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23IBR967; 89) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23GBD741; 90) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23EBW271; 91) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23DBQ920; 92) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 23CBI776; 93) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22OBL140; 94) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22LBL870; 95) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22JBL998; 96) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBO559; 97) DYNJ0305809O, UDI-DI: 10195327110932(each), 40195327110933(case), Lot Number: 22HBF833; 98) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 24DBT971; 99) DYNJ0305809P, UDI-DI: 10195327572914(each), 40195327572915(case), Lot Number: 23LBR942; 100) DYNJ0408776Y, UDI-DI: 10195327115852(each), 40195327115853(case), Lot Number: 23DBS739; 101) DYNJ04596K, UDI-DI: 10193489301342(each), 40193489301343(case), Lot Number: 23KMD949; 102) DYNJ35243L, UDI-DI: 10195327638733(each), 40195327638734(case), Lot Number: 24FMB808; 103) DYNJ49098I, UDI-DI: 10193489712100(each), 40193489712101(case), Lot Number: 21BBP868; 104) DYNJ53089B, UDI-DI: 10193489335248(each), 40193489335249(case), Lot Number: 21BBA722; 105) DYNJ53799, UDI-DI: 10889942444557(each), 40889942444558(case), Lot Number: 21ADA264; 106) DYNJ58704A, UDI-DI: 10193489502053(each), 40193489502054(case), Lot Number: 23CBT449; 107) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21KLA157; 108) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA398; 109) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21HLA233; 110) DYNJ60100C, UDI-DI: 10193489885422(each), 40193489885423(case), Lot Number: 21GLB218; 111) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 22ABJ128; 112) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21FBS847; 113) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR913; 114) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21EBR912; 115) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBO518; 116) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21DBJ319; 117) DYNJ60792B, UDI-DI: 10193489225532(each), 40193489225533(case), Lot Number: 21CBC497; 118) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23LBN124; 119) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23KBH242; 120) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23HBY836; 121) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23EBM305; 122) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23DBB793; 123) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 23CBE668; 124) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22OBE182; 125) DYNJ60792C, UDI-DI: 10195327126964(each), 40195327126965(case), Lot Number: 22HBN525; 126) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23LBG606; 127) DYNJ61157C, UDI-DI: 10195327470234(each), 40195327470235(case), Lot Number: 23KBP559; 128) DYNJ61157D, UDI-DI: 10195327605919(each), 40195327605910(case), Lot Number: 24ABQ754; 129) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25KBL642; 130) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBR218; 131) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25HBG888; 132) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 25ABG065; 133) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24IBQ689; 134) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24GBA833; 135) DYNJ61168D, UDI-DI: 10195327606077(each), 40195327606078(case), Lot Number: 24CBB175; 136) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBX534; 137) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22CBP375; 138) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 22ABL607; 139) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBE011; 140) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB714; 141) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21LBB713; 142) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21KBA371; 143) DYNJ61740D, UDI-DI: 10193489422719(each), 40193489422710(case), Lot Number: 21DBV445; 144) DYNJ61998, UDI-DI: 10193489615012(each), 40193489615013(case), Lot Number: 23EBV072; 145) DYNJ64570A, UDI-DI: 10195327242800(each), 40195327242801(case), Lot Number: 22LBK925; 146) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23GBG567; 147) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23FBJ662; 148) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23DBP210; 149) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBT224; 150) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23CBR140; 151) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 23BBS499; 152) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22LBK279; 153) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22IBV281; 154) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22GBR040; 155) DYNJ67835, UDI-DI: 10193489444810(each), 40193489444811(case), Lot Number: 22EBL897; 156) DYNJ80849B, UDI-DI: 10195327443689(each), 40195327443680(case), Lot Number: 23GBF525; 157) DYNJ80849J, UDI-DI: 10198459561245(each), 40198459561246(case), Lot Number: 25KBJ851; 158) DYNJ84653A, UDI-DI: 10195327697419(each), 40195327697410(case), Lot Number: 24GBU616; 159) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22OBE679; 160) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22KBC323; 161) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22JBY355; 162) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBR893; 163) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ992; 164) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22HBJ991; 165) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22ELA806; 166) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22EBB675; 167) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 22CLA766; 168) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21LBG281; 169) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21JBQ824; 170) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21HBI172; 171) DYNJ900904J, UDI-DI: 10193489906615(each), 40193489906616(case), Lot Number: 21GBF913; 172) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25BME471; 173) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 25AMG870; 174) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24LMD278; 175) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24KMG047; 176) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMF168; 177) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24JMB004; 178) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24HMA754; 179) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24FMF700; 180) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMH051; 181) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24DMB555; 182) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24CBN849; 183) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 24ABH283; 184) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23KBH986; 185) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23JBF549; 186) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23HBQ501; 187) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23GBW505; 188) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBV444; 189) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23FBN975; 190) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABR127; 191) DYNJ900904K, UDI-DI: 10195327290269(each), 40195327290260(case), Lot Number: 23ABC415; 192) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25FMG005; 193) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMJ902; 194) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25EMG513; 195) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25DME524; 196) DYNJ900904L, UDI-DI: 10198459272554(each), 40198459272555(case), Lot Number: 25CMJ212; 197) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25HMI564; 198) DYNJ900904M, UDI-DI: 10198459408519(each), 40198459408510(case), Lot Number: 25GMI512; 199) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21GDB745; 200) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21FDA224; 201) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21EDA724; 202) DYNJ902585, UDI-DI: 10889942117529(each), 40889942117520(case), Lot Number: 21CDB697; 203) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25DDB556; 204) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 25ADA139; 205) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24LDA154; 206) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24JDC387; 207) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24GDA318; 208) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 24CDA135; 209) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23IDB360; 210) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23FDA576; 211) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 23ADA425; 212) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22IDA639; 213) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22HDB311; 214) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22GDB053; 215) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 22FDB376; 216) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21LDA963; 217) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21JDC066; 218) DYNJ902585A, UDI-DI: 10193489985412(each), 40193489985413(case), Lot Number: 21IDB884; 219) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23GDA913; 220) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23FDB736; 221) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23EDB018; 222) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 23BDB148; 223) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22LDA043; 224) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDB239; 225) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22IDA609; 226) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22HDC481; 227) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDB437; 228) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22GDA427; 229) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22EDA370; 230) DYNJ908393, UDI-DI: 10195327067595(each), 40195327067596(case), Lot Number: 22BDB502; 231) DYNJ908393A, UDI-DI: 10195327490416(each), 40195327490417(case), Lot Number: 23KDA234; 232) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25FLA327; 233) DYNJ909573, UDI-DI: 10195327404741(each), 40195327404742(case), Lot Number: 25DLA489; 234) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24FBF785; 235) DYNJ910384, UDI-DI: 10195327661595(each), 40195327661596(case), Lot Number: 24EBH096; 236) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25DBC086; 237) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF621; 238) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25CBF584; 239) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25BBN770; 240) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 25ABA025; 241) DYNJ910384A, UDI-DI: 10198459096396(each), 40198459096397(case), Lot Number: 24JBQ224; 242) PHS390015M, UDI-DI: 10193489333824(each), 40193489333825(case), Lot Number: 20LMD456
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.