BEUDAMED
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    Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KDD·November 17, 2022

    Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

    FDA Recall
    Terminated ·Sekisui Diagnostics P.E.I. Inc.·Product code JIF·November 29, 2016

    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.

    FDA Recall
    Terminated ·JK Products & Services, Inc·Product code LEJ·July 8, 2005

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

    FDA Recall
    Open, Classified ·HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom·Product code MKJ·September 18, 2025

    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

    FDA Recall
    Open, Classified ·HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom·Product code MKJ·April 26, 2023

    Custom Pak (Custom Pak in which Alcon 25+ TOTALPLUS Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.

    FDA Recall
    Terminated ·Alcon Research, LTD. 9965 Buffalo Speedway·Product code HQC·January 12, 2018

    The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code LRO·April 28, 2015

    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).

    FDA Recall
    Terminated ·Given Imaging Ltd.·Product code NEZ·March 8, 2011

    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing.

    FDA Recall
    Terminated ·Heartsine Technologies, Limited 203 Airport Road West Belfast United Kingdom·Product code MKJ·June 12, 2014

    Alcon Custom Pak

    FDA Recall
    Terminated ·Alcon Research, LTD. 9965 Buffalo Speedway·Product code LRO·August 8, 2017

    Constellation Procedure Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Centurion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Alcon Custom Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Legion FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Infinity FMS Pak

    FDA Recall
    Open, Classified ·Alcon Research, LTD.·Product code HQC·June 28, 2023

    Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code LRO·July 15, 2024

    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.

    FDA Recall
    Terminated ·Halyard Health, Inc·Product code BSY·July 29, 2015

    Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code LRO·April 28, 2025