FDA Device recall Z-1436-2024
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825
- FDA Device
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825 by Medline Industries Northfield, citing product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1436-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-23 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Reason
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Identifiers
| code_info | a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI…a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690 |
|---|
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-1436-2024%22
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