Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

FDA Recall Z-0234-2026 · Posted 2025-10-23

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeNGT
Date Initiated2025-09-11
Product Quantity8,267,150 syringes

Reason for Recall

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

Firm 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 credit for the destroyed affected units. For questions, please contact the Recall Department at 866-359-1704 or [email protected].

Root Cause

Process control

Distribution Pattern

Distribution US nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. · 2018-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑