Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syrin
FDA device recall Z-0234-2026 · posted 2025-10-23 · Open, Classified
Recall details
- Recalling firm
- Medline Industries, LP
- Reason for recall
- Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
- Action taken
- Medline issued an Urgent Medical Device Recall notice to its consignees on 9/11/2025 via email and mail. The notice discussed the issue, potential risk, and noted that affected boxes of syringes were also inadvertently packaged within cases of syringe lots that meet all requirements and were still safe for use. Within the item number, EMZ111240, the firm specified which lots were to be destroyed and which lots were safe to use. Cases of certain lots labeled with safe to use codes must be opened and inspected for affected units which must be destroyed. A response is required to receive credit for the destroyed affected units. For questions, please contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NGT
- Quantity affected
- 8,267,150 syringes
- Distribution
- Distribution US nationwide and Canada
- Date initiated
- 2025-09-11
- Date posted
- 2025-10-23
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0.9% Sodium Chloride Injection, USP (K173348) | Medline Industries, Inc. | 2018-06-21 |