# FDA recall Z-2107-2026

> **Medline Industries, LP** · Class II · device recall initiated 2026-01-07.

## 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

## 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

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2107-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-07
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2026

## Citation

> AI Analytics. FDA recall Z-2107-2026. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2107-2026. Source: US FDA. Licensed CC0.

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