BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

    Recall: Z-2263-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2263-2026
    Event ID
    98862
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B Braun Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    January 29, 2026
    Classification Date
    May 29, 2026
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524, United States

    Description

    Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

    Reason

    B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

    Code Info

    Lot Code: Model No 555076, UDI-DI (Primary Device) 04046964313417, UDI-DI (Unit Device ID) 04046964313394, Lot Number 0062031523 Note: In the original customer notification (JAN2026), 280 pieces were distributed, to date, all pieces have been returned.

    Distribution

    US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

    Quantity

    280