Excelsior Medical — Class II medical device recall Z-0234-2026
Ongoing recall by Medline Industries, LP, reported 2025-10-29, distributed nationwide. Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentra
| Recall number | Z-0234-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 8,267,150 syringes |
| UPC / GTIN / UDI-DI | 00363807000032, 00363807100114, 10363807000039 |
| Lot numbers | 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158 |
| Model numbers | EMZ111240 |
Product
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Reason for recall
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
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-0234-2026. 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.