Medline Industries, LP: Device Recall

Recall #Z-0922-2026 · 11/13/2025

Class II: Risk

Recall Details

Recall Number: Z-0922-2026
Classification: Class II
Product Type: Device
Recalling Firm: Medline Industries, LP
Status: Ongoing
Date Initiated: 11/13/2025
Location: Northfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 53 units

Reason for Recall

The items may have weak packaging seals that may result in a breach of sterility if the seal fails and may lead to an increased risk of infection if product is utilized.

Product Description

FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048

Distribution Pattern

US Nationwide distribution in the states CA, CO, IL, KS, and MI.

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.