Recall Z-0234-2026 ยท NGT Saline, Vascular Access Flush
Medline Industries, LP
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
| Date | Oct 23, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| Reason | Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. |
| Root cause | Process control |
| Action | 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 cre |
| Quantity | 8,267,150 syringes |
| Distribution | Distribution US nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173348 | 0.9% Sodium Chloride Injection, USP Medline Industries, Inc., Jun 21, 2018 |