BEUDAMED
    80 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    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

    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

    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

    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

    Alcon Custom Pak Surgical Procedure Pack

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code LRO·October 31, 2022

    GEM Premier 5000 PAK; Part No. 00055415004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360010.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055407510.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK, Part No. 00055360004.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360011.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055360008.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055407508.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055407511.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026

    GEM Premier 5000 PAK; Part No. 00055407504.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code CHL·January 20, 2026