Medline Industries, LP: Device Recall

Recall #Z-0510-2026 · 10/03/2025

Class II: Risk

Recall Details

Recall Number: Z-0510-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medline Industries, LP
Status: Ongoing
Date Initiated: 10/03/2025
Location: Northfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1024 units

Reason for Recall

Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.

Product Description

MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

Distribution Pattern

US: MO

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.