BEUDAMED
    FDA Recall Open, Classified

    Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

    Recall: Z-1089-2026 · Initiated December 16, 2025

    Recall

    Recall Number
    Z-1089-2026
    Event Number
    98197
    FEI Number
    1417592
    Product Code
    OJF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 16, 2025
    Posted
    January 14, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

    Reason

    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.

    Action

    Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following: "1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2.Please use the link and the information below to complete your response form. Please list the quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form. Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4.If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected]."

    Distribution

    US Nationwide distribution.

    Quantity

    1457 units