FDA Device recall Z-0558-2025
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case by Medline Industries Northfield, citing identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer bo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0558-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-25 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Reason
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
Identifiers
| code_info | UDI-DI: 10193489844115 (each), 40193489844116 (case); Lot Number 22EBD372 |
|---|
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-0558-2025%22
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