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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