FDA Device recall Z-1810-2025
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- FDA Device
- Class I
- ongoing
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class I recall of Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C by Medline Industries Northfield, citing affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1810-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-04-22 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA, WI |
Product
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Reason
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Identifiers
| code_info | UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1810-2025%22
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