64 results
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38ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
FDA Recall
Open, Classified
·Covidien Llc·Product code CCK·November 16, 2020
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code BTT·April 2, 2024
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
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code OCX·March 31, 2026
Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.
FDA Recall
Open, Classified
·Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany·Product code KTI·October 17, 2018
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code OCX·March 31, 2026
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code GTY·July 30, 2025
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
FDA Recall
Open, Classified
·Luminex Molecular Diagnostics Inc·Product code QLT·September 5, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
FDA Recall
Open, Classified
·Luminex Molecular Diagnostics Inc·Product code OCC·September 5, 2024
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
FDA Recall
Open, Classified
·Microbiologics Inc·Product code OHQ·February 20, 2025
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207; ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248; Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208
FDA Recall
Open, Classified
·Erbe Medical, LLC·Product code FEQ·March 31, 2026
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
FDA Recall
Open, Classified
·Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand·Product code QAV·August 7, 2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
FDA Recall
Open, Classified
·Cypress Medical Products LLC·Product code GTZ·August 20, 2024
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
FDA Recall
Open, Classified
·Cypress Medical Products LLC·Product code GTY·August 20, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·September 12, 2024
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during anesthesia.
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code BSZ·January 15, 2025
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
FDA Recall
Open, Classified
·Copan Italia Via Francesco Perotti 10·Product code PPM·October 29, 2025
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·May 8, 2026
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System
FDA Recall
Open, Classified
·Copan Italia Via Francesco Perotti 10·Product code PPM·October 29, 2025
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2) and respiratory rate (RR). The EtCO2 module and disposables are indicated for use with intubated and nonintubated adult, pediatric and neonatal patients. It is not intended for direct connection to ventilator or breathing systems. Only one EtCO2 module can be connected to the Alaris System.
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code PHC·August 4, 2020