88 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
FDA Recall
Open, Classified
·Breas Medical, Inc.·Product code NOU·July 25, 2024
with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
FDA Recall
Open, Classified
·Breas Medical, Inc.·Product code NOU·October 13, 2023
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
FDA Recall
Open, Classified
·Breas Medical, Inc.·Product code NOU·June 2, 2022
Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code JJE·February 29, 2024
YSIO X.Pree
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code KPR·March 7, 2022
Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code BXN·May 17, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FJK·August 15, 2024
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
FDA Recall
Open, Classified
·Medline Industries Inc·Product code LRO·April 30, 2021
B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606108-02
FDA Recall
Open, Classified
·B. Braun Medical, Inc.·Product code FMF·August 7, 2023
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
FDA Recall
Open, Classified
·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024