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

    Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

    FDA Recall
    Open, Classified ·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·August 30, 2024

    Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    FDA Recall
    Open, Classified ·Product code DTL·March 24, 2026

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·February 7, 2024

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

    FDA Recall
    Open, Classified ·Mercury Enterprises, Inc. dba Mercury Medical·Product code BTL·December 10, 2024

    Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KIT MANIFOLD CSTM-RENAISSANC, Pack Number 134085 ; 4) KIT LEFT HEART- LEXINGTON , Pack Number 142643 ; 5) KIT ANGIO CSTM-SETON, Pack Number 143267; 6) SYR- VA HOSPITAL, Pack Number 144684; 7) BYPASS ENCOMPASS CDS, Pack Number CDS985003A; 8) CSTM MANIFOLD KIT , Pack Number SAMPC0547; 9) CSTM MANIFOLD KIT - FRYE, Pack Number VASC1074 ; 10) CSTM MANIFOLD KIT , Pack Number VASC1130

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code DTL·April 8, 2024

    10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·July 25, 2025

    WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DTL·April 5, 2023

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    FDA Recall
    Open, Classified ·Product code DTL·March 24, 2026

    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and fatigue that results from manual actuation. PREVENT is indicated for emergency resuscitation with appropriate patient monitoring on adult patients that require mechanical respiratory support.

    FDA Recall
    Open, Classified ·Precision Valve & Automation, Inc·Product code BTL·June 26, 2020

    Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    FDA Recall
    Open, Classified ·Product code DTL·March 24, 2026

    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·August 4, 2025

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.

    FDA Recall
    Open, Classified ·Product code DTL·February 27, 2026

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·February 7, 2024

    Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code BTL·May 31, 2024

    WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DTL·April 5, 2023