BEUDAMED
    FDA Enforcement Class I Ongoing

    Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH

    Recall: Z-1320-2026 · Reported February 18, 2026

    Enforcement

    Recall Number
    Z-1320-2026
    Event ID
    98277
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2026
    Initiation Date
    December 22, 2025
    Classification Date
    February 6, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH

    Reason

    These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

    Code Info

    81105RH UDI-DI 10197344133253 Lot EP250618; 81172RH UDI-DI 10197344133284 Lot EP250618; 81202RH UDI-DI 10197344133307 Lot EP250618; 81483RH UDI-DI 10197344133444 Lot EP250618; 81102RH UDI-DI (case) 20197344133236¿ (ea) 10197344133239 Lot EP250618; 81104RH UDI-DI 10197344133246 Lot EP250618; 81174RH UDI-DI 10197344133291 Lot EP250618; 81531RH UDI-DI 10197344133512 Lot EP250618; 81532RH UDI-DI 10197344133529 Lot EP250618; 81107RH UDI-DI 10197344133260 Lot EP250618; 81402RH UDI-DI 10197344133352 Lot EP250618; 81404RH UDI-DI 10197344133376 Lot EP250618; 81405RH UDI-DI 10197344133383 Lot EP250618; 81474RH UDI-DI 10197344133437 Lot EP250618; 81473RH UDI-DI 10197344133420 Lot EP250618

    Distribution

    Distribution US nationwide.

    Quantity

    311