Medline Industries Recalls 7,494 Neuro Convenience Kits Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary Class II recall of various Medline Convenience Kits used in neurosurgical procedures. The company identified issues related to the calibration of equipment used to sterilize and package the devices. While all affected products were exposed to validated sterilization and packaging cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the products.

Which Products Are Affected

The recall involves 7,494 units distributed worldwide and nationwide across the United States. Affected products include 43 different kit configurations with various model numbers and lot codes. Key products include:

• NEURO SHUNT- CODMAN: Models CDS860018G and CDS860018I
• KIT NEUR FUS LUM POST: Models DYKMBNDL138, DYKMBNDL142, DYKMBNDL142B
• KIT NEURO DECOMPRESSIVE CRANIO: Models DYKMBNDL145, DYKMBNDL145B
• KIT NEURO TRANSPHENOIDAL: Models DYKMBNDL5, DYKMBNDL5B
• NEURO PACK-LF: Models DYNJ0305809O, DYNJ0305809P, DYNJ0408776Y, DYNJ04596K, PHS390015M
• DISCECTOMY PACK: Model DYNJ67835
• NEURO PACK: Models DYNJ49098I, DYNJ53089B, DYNJ60100C, DYNJ60792B, DYNJ60792C, DYNJ61157C, DYNJ61157D, DYNJ61168D, DYNJ61740D, DYNJ80849B, DYNJ80849J
• Other Neuro Kits: Models DYNJ53799, DYNJ58704A, DYNJ61998, DYNJ64570A, DYNJ84653A, DYNJ900904J, DYNJ900904K, DYNJ900904L, DYNJ900904M, DYNJ902585, DYNJ902585A, DYNJ908393, DYNJ908393A, DYNJ909573, DYNJ910384, DYNJ910384A

Official Recall Number: Z-1413-2026.

What You Should Do

Medline Industries initiated the recall on January 7, 2026, by sending notification letters to affected customers. Healthcare facilities and distributors should identify any remaining stock of the affected lot numbers and follow the instructions provided in the firm’s notification letter. For questions or further information, the recalling firm is located at 3 Lakes Dr, Northfield, IL 60093-2753.

Why This Matters

Because these kits are used in sensitive neurosurgical environments, any potential compromise to the sterility assurance level could pose a risk of infection or other complications for patients.

Source

This information is based on official recall data from the FDA.