FDA Upgrades Medline Craniotomy Kit Recall to Most Serious Class
The FDA has reclassified the recall of Medline craniotomy kits as Class I, the most serious type, due to a risk of severe injury or death.
3 reports on this incident · first at Aug 7, 2026, 8:28 p.m. ET
Earlier reports
Aug 20, 2026, 3:36 p.m. ET
FDA Recall Notice for Medline Craniotomy Kits States No Injuries or Deaths Reported
The U.S. Food and Drug Administration's recall record for Medline Craniotomy Kits states that "There have been no reported injuries. There have been no reports of death." The fact set available for this story contains no agency statement of any injury or illness attributed to the recalled devices; on the record as it stands, no harm has been reported to the agency.
The recall, which the FDA classifies as the most serious type, was initiated on April 22, 2025 and covers Medline convenience kits containing the Codman Disposable Perforator 14 mm, a single-use surgical tool used in neurosurgical procedures to drill access holes into the skull. According to the FDA, Integra LifeSciences is recalling the perforators because of an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure.
The agency lists the potential hazard as serious adverse health consequences, including tears in the membrane surrounding the brain (dura), bleeding, brain tissue bruising (contusions), irreversible brain damage, and death. That is a stated potential hazard, not a description of any outcome the agency says has occurred.
The FDA says that on April 22, 2025, Medline Industries, LP sent all affected customers an Immediate Action Required Voluntary Medical Device Recall notice. Customers in the U.S. with questions about the recall are directed to contact Medline's Recall Department at 866-359-1704 or recalls@medline.com. The FDA notice lists the affected products by SKU, UDI-DI and lot number, including Craniotomy Kit SKU DYNJ35349C (lots 24CBJ925, 24DBT405, 24FBO318) and CRANI PACK-LF SKU DYNJ44805M (lots 23JBI747, 23KBL228, 24ABG696, 24CBM117, 24EBQ114, 24GBJ699), among more than 20 other kit configurations.
Aug 7, 2026, 8:28 p.m. ETFirst report
FDA Lists Medline Craniotomy Kit Recall as Most Serious Class Over Perforator Weld Defect
The U.S. Food and Drug Administration has posted a recall of Medline Craniotomy Kits made by Medline Industries, LP, classifying it as the most serious type 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, Integra LifeSciences is recalling the Codman Disposable Perforators 14mm due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure.
The FDA states the hazard may cause serious adverse health consequences, including tears in the membrane surrounding the brain (dura), bleeding, brain tissue bruising (contusions), irreversible brain damage, and death. 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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First published.
- Version 120 Aug 2026, 19:36current
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- Version 120 Aug 2026, 20:25current
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