Medline Industries, LP: Device Recall

Recall #Z-2670-2025 · 08/21/2025

Class I: Dangerous

Recall Details

Recall Number: Z-2670-2025
Classification: Class I
Product Type: Device
Recalling Firm: Medline Industries, LP
Status: Ongoing
Date Initiated: 08/21/2025
Location: Northfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 828 units

Reason for Recall

The kits contain certain lots of cannula products where the catheter may not retain its shape.

Product Description

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Distribution Pattern

US Nationwide distribution in the state of CA.

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.