BEUDAMED
    37 results · 18ms · Sources: EU EUDAMED, US FDA

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    LDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.

    FDA Recall
    Terminated ·LDR Spine USA, Inc.·Product code LXH·August 29, 2016

    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 1000080 and 0048-0045 - Impella CP with SmartAssist ***Updated February 2024*** (10) 004413 - Impella 2.5 Set (12) 0046-0026 - Impella 5.0 Pump Set ROW (13) 0046-0037 - Impella 5.0 Pump Set APAC (15) 004680-AU - 5.0 Pump Set AU (16) 0048-0002 - Impella CP Pump Set, EU (17) 0048-0002-BR - Impella CP Pump Set BR (18) 0048-0004 - Impella CP Pump Set, Canada (19) 0048-0014 - Impella CP Smart Assist Set, EU (20) 0048-0024-JP - Impella CP Smart Assist Set, JP (21) 0048-0044 - Impella CP Smart Assist Set, Canada (22) 0048-0047 - Impella CP Smart Assist Set APAC (23) 005040 - Impella 2.5 IMC Pump Set EU (24) 005048-JP - Impella 2.5 Pump Set, Japan (25) 005060 - Impella 5.0 IMC Pump Set EU (26) 005064 - Impella 5.0 IMC Pump Set Canada (27) 005066-JP - Impella 5.0 Pump Set, Japan (28) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (29) 0550-0004 - Impella 5.5 with SmartAssist Set, CA (30) 1000115 - Impella CP Pump set, APAC (31) 1000211 - Impella 5.5 SmartAssist Set, JP (32) 1000302 - Impella CP with SmartAssist APAC (33) 1000361 - Impella 5.5 Set AU (34) 1000402 - Impella CP Smart Assist Set ***Updated March 15, 2024*** The following products were removed from the list of affected products because the Right-side devices are not in the scope of the warning to avoid left ventricle perforation: (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (11) 0046-0011 - Impella RP Pump Set, EU (14) 0046-0039 - Impella RP Set APAC

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·December 27, 2023

    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·December 27, 2023

    Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDZ·March 21, 2018

    Men s Hormone Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CDZ·November 3, 2025

    IMMULITE 2000 Total Testosterone Kit

    FDA Recall
    Terminated ·Diagnostic Products Corp.·Product code CDZ·January 3, 2006

    VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DLZ·June 12, 2013

    Clinical Chemistry Phenobarbital, list number 1E08

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DLZ·November 16, 2012

    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018

    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·November 30, 2018

    The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.

    FDA Recall
    Open, Classified ·Qualigen Inc·Product code CDZ·December 3, 2024

    Access Testosterone assay, Catalog Number 33560

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code CDZ·May 5, 2025

    VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Phenobarbital) Slides --- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- Ortho-Clinical Diagnostics High Wycombe, UK --- This is an in vitro diagnostic. For in vitro diagnostic use only. VITROS Chemistry Products PHBR Slides quantitatively measure Phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DLZ·June 23, 2011

    IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CDZ·October 25, 2022

    VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DLZ·March 14, 2013

    Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDZ·July 26, 2010

    ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CDZ·March 5, 2018

    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DLZ·July 30, 2012