Excelsior recallZ-0234-2026 · Medline Industries, LP · initiated Sep 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medline Industries, LP or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
FDA root cause category: Process control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0234-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 23, 2025
- Recalling firm
- Medline Industries, LP
- Quantity
- 8,267,150 syringes
- Product code
- NGT
- FDA submissions
- K173348
- Distribution
- Distribution US nationwide and Canada
Product description
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Code information (models, lots, serial numbers)
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Excelsior 10011Medline Industries, Inc. · Saline, vascular access flush1 recall6 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K173348 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MEDLINE EMZE010001Medline Industries, Inc. · Saline, vascular access flush4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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