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Recall

Class II — Medline Industries, LP

Recalling firmMedline Industries, LP
Registered facilityView this company's 31 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonMedline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
ProductExcelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Quantity8,267,150 syringes
DistributionDistribution US nationwide and Canada
Initiated2025-09-11
Classified2025-10-23
Recall numberZ-0234-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medline Industries, LP (Z-0234-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97675/

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