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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 1,853
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
Part of a larger recall action
This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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