BEUDAMED
    FDA Enforcement Class II Ongoing

    Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

    Recall: Z-0178-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0178-2026
    Event ID
    97659
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 4, 2025
    Classification Date
    October 16, 2025
    Address
    1601 Se Gateway Dr Ste 120, Grimes, IA, 50111-5223, United States

    Description

    Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951

    Reason

    Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

    Code Info

    RCEN25B UDI-DI 191072225115 lot 8138311 bag serial number N/A; RCHN27D UDI-DI 191072235923 lot 8508211 bag serial number 47847459 * If bag serial number is listed as "n/a", then entire lot is affected

    Distribution

    US Nationwide distribution in the states of SD, IA, MN, WA, IL.

    Quantity

    32,433 total