ENDO KIT — Class II medical device recall Z-0558-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-12-04, distributed nationwide. Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates o
| Recall number | Z-0558-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-10-25 |
| Classified | 2024-11-26 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 100 |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10193489844115, 40193489844116 |
| Lot numbers | 22EBD372 |
Product
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0558-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.