Medline Industries, LP recalls Excelsior Medical

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0234-2026
• FDA 510(k) clearance · K173348The device's official FDA premarket clearance record
• FDA device classification · NGTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5200The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medline Industries, LPSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.