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Sources: EU EUDAMED, US FDA
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FDA Recall
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Vicks brand Warm Mist Humidifier, Model V610, ''Pure Warm Moisturizer for Soothing Relief of Cold and Flu Symptoms'' sold over the counter. Firm on the label: Distributed by Kaz Inc., under license from the Procter & Gamble Company, Cincinnati, OH 45202. UPC code 3 28785 20610 4.
FDA Recall
Terminated
·Product code KFZ·April 15, 2003
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·March 10, 2014
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
FDA Recall
Terminated
·CooperVision Inc.·Product code MVN·August 28, 2009
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
FDA Recall
Open, Classified
·Philips North America Llc·Product code MHX·June 28, 2024
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·January 20, 2017
Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·October 26, 2016
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
FDA Recall
Open, Classified
·Envisiontec US Llc·Product code EBZ·January 20, 2022
HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·May 12, 2008
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·September 29, 2023
Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·October 26, 2016
HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal, Eyes on Top, Atrium Code # 14709, Size 9mm, # Eyelets 6, 10 per case
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·May 12, 2008
TERUMO KHURI MYOCARDIAL PH MONITORING SYSTEM, CATALOG NUMBER 7205
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code CBZ·June 23, 2006
Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·October 26, 2016
Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·October 26, 2016
Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·October 26, 2016
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028
FDA Recall
Open, Classified
·Atrium Medical Corporation·Product code GBZ·April 21, 2022
Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBZ·January 20, 2017