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) Ki

Recall Summary Medline is recalling 43 neurosurgical convenience kits with various model numbers due to calibration issues with the sterilization and packaging equipment used to process them. While all products went through sterilization cycles, the calibration problems could potentially affect whether the devices maintain their sterility. This recall affects neurosurgical kits that may have been distributed to hospitals and surgical facilities.

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)...

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 I

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1b209d3f-f590-46e5-b00d-9b2bee137267