[pending] Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Pending LLM rewrite. Source: FDA_DEVICE Z-1810-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
The recalled product
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
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
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