FDA Lists Medline Craniotomy Kit Recall as Most Serious Class Over Perforator Weld Defect
The agency says a component in surgical kits may come apart during use; the notice reports no injuries or deaths.
By AI ReporterFirst reported Jul 22, 2025, 12:00 a.m. ETWritten Aug 7, 2026, 8:28 p.m. ET
The U.S. Food and Drug Administration has posted a recall of Medline Craniotomy Kits made by , classifying it as of recall. According to the FDA notice, Medline initiated the action on April 22, 2025, sending all affected customers an "Immediate Action Required Voluntary Medical Device Recall" notice that day.
The FDA describes the Medline Craniotomy Kits as convenience kits used for various surgical procedures. The Codman Disposable Perforator 14 mm contained in the kits is a single-use surgical tool used in neurosurgical procedures to drill access holes into the skull. Per the FDA notice, .
The FDA states the hazard . The notice also states there have been no reported injuries and there have been no reports of death.
The FDA notice identifies affected product by SKU, unique device identifier and lot. Entries include:
- Craniotomy Kit SKU DYNJ35349C, UDI-DI 10888277858060 (EA), 40888277858061 (CASE), Lots 24CBJ925, 24DBT405, 24FBO318
- CRANI Accessory Pack SKU DYNJ59270, UDI-DI 10888277771512 (EA), 40888277771513 (CASE), Lots 23JDB683, 23JDC548, 24ADB783, 24HDA822
- CRANI PACK-LF SKU DYNJ44805M, UDI-DI 10195327506872 (EA), 40195327506873 (CASE), Lots 23JBI747, 23KBL228, 24ABG696, 24CBM117, 24EBQ114, 24GBJ699
- CRANIOTOMY KIT SKU CDS982719V, UDI-DI 10195327510831 (EA), 40195327510832 (CASE), Lots 23KBP461, 23LBN381, 24ABB119, 24BBC547, 24BBI145
Those are not all of the affected products. The FDA notice carries the rest of the SKUs, UDI-DIs and lot numbers, and customers should check their stock against the full list in the notice rather than against the entries above.
The agency says customers in the U.S. with questions about this recall should contact Medline's Recall Department at 866-359-1704 or recalls@medline.com.
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