BEUDAMED
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    Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code OYK·November 17, 2011

    IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HTY·July 9, 2024

    Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·October 6, 2025

    HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

    FDA Recall
    Terminated ·HemoSense Inc·Product code GJS·September 7, 2005

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Completed ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018

    ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 7, 2018

    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

    FDA Recall
    Completed ·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018

    MicroAire K-Wires

    FDA Recall
    Terminated ·MicroAire Surgical Instruments, LLC·Product code HTY·February 21, 2017

    SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147

    FDA Recall
    Terminated ·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FSM·November 15, 2016

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    FDA Recall
    Terminated ·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FCH·November 15, 2016

    CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.

    FDA Recall
    Terminated ·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code LXH·November 15, 2016

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JWH·October 27, 2023

    BD Beaver Slit Blade 3.0mm Straight Part Number: 375521 The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.

    FDA Recall
    Terminated ·Bd Medical Systems·June 24, 2010

    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

    FDA Recall
    Terminated ·Amendia, Inc·Product code LXH·April 6, 2017

    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·May 30, 2023

    ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    FDA Recall
    Terminated ·Implant Direct Sybron Manufacturing, LLC·Product code DZE·August 8, 2018

    REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·May 30, 2023