BEUDAMED
    65 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code FOZ·March 5, 2026

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

    Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

    FDA Recall
    Terminated ·Dale Medical Products, Inc.·Product code CBH·March 24, 2017

    HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

    FDA Recall
    Open, Classified ·Product code CAH·April 29, 2021

    Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230

    FDA Recall
    Open, Classified ·Product code CAH·October 10, 2025

    AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R2.

    FDA Recall
    Terminated ·Pointe Scientific, Inc.·Product code CCH·June 12, 2006

    SafeStar 90 Plus Filter. Bidirectionally breathing system filter.

    FDA Recall
    Open, Classified ·Draeger, Inc.·Product code CAH·June 16, 2025

    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

    FDA Recall
    Open, Classified ·Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan·Product code CAH·January 9, 2025

    Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

    FDA Recall
    Terminated ·Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom·Product code CAH·June 7, 2005

    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.

    FDA Recall
    Terminated ·Pall Corporation·Product code CAH·June 4, 2014

    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6

    FDA Recall
    Terminated ·King Systems Corp. dba Ambu, Inc.·Product code CAH·March 15, 2017

    Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex free, box of 100 Reorder Numbers: 5553100 (single filter reorder no. 5553000), 5554100 (single filter reorder no. 5554000), 5555100 (single filter reorder no. 5555000), 5559100 (single filter reorder no. 5559000), 7773100 (single filter reorder no. 7773000), and 7774100 (single filter reorder no. 7774000). The firm name on the label is Alliance Tech Medical, Inc., Granbury, TX, manufactured in Taiwan.

    FDA Recall
    Completed ·Alliance Tech Medical, Inc·Product code CAH·October 6, 2014

    Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.

    FDA Recall
    Open, Classified ·Product code CAH·April 29, 2021

    HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024