Recall archive / FDA device enforcement
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS... — FDA record Z-1413-2026
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 Jan 7, 2026. 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
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 7494 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1413-2026
What the recall classes mean. 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) 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: 25ABG0... |
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
Worldwide distribution - US Nationwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 25, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- Feb 17, 2026
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.