FDA Medical devices recall ·
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G recall
- Recall number
- Z-2107-2026
- Date
- (initiated January 7, 2026)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10184 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K; 15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 16) NEURO PACK, Model Number: DYNJ49098I; 17) NEURO PACK, Model Number: DYNJ53089B; 18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 21) NEURO PACK, Model Number: DYNJ60792B; 22) NEURO PACK, Model Number: DYNJ60792C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F; 26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 27) NEURO PACK, Model Number: DYNJ61740D; 28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 30) DISCECTOMY PACK, Model Number: DYNJ67835; 31) FSC NEURO PACK, Model Number: DYNJ80442B; 32) WWD NEURO PACK, Model Number: DYNJ80849B; 33) WWD NEURO PACK, Model Number: DYNJ80849C; 34) WWD NEURO PACK, Model Number: DYNJ80849D; 35) WWD NEURO PACK, Model Number: DYNJ80849F; 36) WWD NEURO PACK, Model Number: DYNJ80849G; 37) WWD NEURO PACK, Model Number: DYNJ80849I; 38) WWD NEURO PACK, Model Number: DYNJ80849J; 39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 40) NEURO, Model Number: DYNJ900904J; 41) NEURO, Model Number: DYNJ900904K; 42) NEURO, Model Number: DYNJ900904L; 43) NEURO, Model Number: DYNJ900904M; 44) NEURO, Model Number: DYNJ902585; 45) NEURO, Model Number: DYNJ902585A; 46) NEURO - IFCAP 230316, Model Number: DYNJ908393; 47) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 48) NEURO - IFCAP 230316, Model Number: DYNJ908393B; 49) NEURO KIT, Model Number: DYNJ909573; 50) NEURO, Model Number: DYNJ910384; 51) NEURO, Model Number: DYNJ910384A; 52) NEURO PACK-LF, Model Number: PHS390015M
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21CBA213; 2) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21DBD719; 3) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMA403; 4) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GME436; 5) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21GMF497; 6) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21JMH357; 7) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21KMD971; 8) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 21LMG598; 9) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22DMD555; 10) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22HMC764; 11) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 22KMF991; 12) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23AMJ086; 13) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMD444; 14) CDS860018G, UDI-DI: 10889942459643(each), 40889942459644(case), Lot Number: 23CMH970; 15) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23EME270; 16) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), Lot Number: 23GMC110; 17) CDS860018I, UDI-DI: 10195327381776(each), 40195327381777(case), L
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2107-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.