32 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·May 10, 2021
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·February 3, 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
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code NOU·March 25, 2026
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251
FDA Recall
Open, Classified
·BioFire Diagnostics, LLC·Product code PEN·October 17, 2023
VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
FDA Recall
Open, Classified
·Percussionaire Corporation·Product code CBK·December 23, 2024
VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
FDA Recall
Open, Classified
·Ventec Life Systems, Inc.·Product code CBK·January 9, 2024
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
FDA Recall
Open, Classified
·Stryker Corporation·Product code KCY·March 1, 2023
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
FDA Recall
Open, Classified
·Stryker Corporation·Product code KCY·July 2, 2025
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
FDA Recall
Open, Classified
·Stryker Corporation·Product code KCY·March 1, 2023
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
FDA Recall
Open, Classified
·Stryker Corporation·Product code KCY·March 1, 2023
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
FDA Recall
Open, Classified
·Navajo Manufacturing Company·Product code IRT·February 18, 2026
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
FDA Recall
Open, Classified
·Whele LLC DBA Perch·Product code IRT·October 24, 2022
Vios Monitoring System Bedside Monitor Model BSM2050
FDA Recall
Open, Classified
·Murata Vios, Inc.·Product code DRT·August 9, 2024
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
FDA Recall
Open, Classified
·Murata Vios, Inc.·Product code DRT·June 6, 2023
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
FDA Recall
Open, Classified
·Whele LLC DBA Perch·Product code IRT·October 24, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Recall
Open, Classified
·Whele LLC DBA Perch·Product code IRT·October 24, 2022
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA Recall
Open, Classified
·Murata Vios, Inc.·Product code DRT·April 22, 2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024
Intelli-C, Left side suspended Tabletop, REF: 03400010
FDA Recall
Open, Classified
·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 27, 2023