Medline Industries, LP: Device Recall

Recall #Z-0234-2026 · 09/11/2025

Class II: Risk

Recall Details

Recall Number: Z-0234-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medline Industries, LP
Status: Ongoing
Date Initiated: 09/11/2025
Location: Northfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,267,150 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.

Product Description

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

Distribution Pattern

Distribution US nationwide and Canada

Other Recalls by Medline Industries, LP

Class II: Risk 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.

View all recalls by Medline Industries, LP →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.