Medline Craniotomy Kits with Defective Codman Disposable Perforators
Medline is recalling craniotomy kits containing Codman Disposable Perforators with inadequate welds that may break or separate during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall involving surgical equipment with a structural defect (inadequate welds) that could fail during a critical procedure. The hazard involves potential equipment failure during cranial surgery, which poses significant risk of harm during invasive procedures.
Plain-English summary
Medline Industries, LP is recalling 1,853 Medline Kits containing Codman Disposable Perforator 14 mm for craniotomy procedures (SKU DYNJ35349C). The kits contain recalled Integra Lifesciences Codman Disposable Perforators that have inadequate welds on specific lots.
Perforators with inadequate welds may break or separate during use, which could compromise the safety and effectiveness of the surgical procedure.
The affected kits were distributed throughout the United States to California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, New York, Texas, Vermont, Washington, and Wisconsin. The recalled kit lots are 24CBJ925, 24DBT405, and 24FBO318.
Customers who have received these kits should stop using them immediately and contact Medline Industries, LP for further instructions regarding return or replacement.
The recalled product
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- structural-defect
- equipment-failure
- weld-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 10888277858060 (EA)
- 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318
Distribution
Distributed in 13 states:
- CA
- FL
- IL
- IN
- KY
- MA
- MD
- MN
- NY
- TX
- VT
- WA
- WI
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22