CLASS II ONGOING Device recall · Reported 29 Oct 2025 · FDA Enforcement Report
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - Fill recalled
Medline Industries is recalling Excelsior Medical, 0.9% Sodium Chloride Injection, USP - Fill, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0234-2026
- FDA event ID
- 97675
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2025
- FDA classified
- 23 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 11 Sep 2025 | Recall initiated by company | |
| 23 Oct 2025 | Classified by FDA | +42 days |
| 29 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Where it was distributed
Distribution US nationwide and Canada
Questions about this recall
Why was it recalled?
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Which lots are affected?
UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,
Where was it sold?
Distribution US nationwide and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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