FDA Device recall Z-0754-2025
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 by Medline Industries Northfield, citing weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0754-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-12 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Reason
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Identifiers
| code_info | UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990 |
|---|
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-0754-2025%22
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