59 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Animas ezManager Max Diabetes Management System version 2.0.9
FDA Recall
Terminated
·Animas Corporation·Product code MRZ·November 2, 2009
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·July 29, 2019
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·July 29, 2019
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·July 29, 2019
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code MRZ·December 19, 2023
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·July 29, 2019
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·July 29, 2019
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
FDA Recall
Terminated
·ICU Medical Inc·Product code MRZ·November 8, 2018
MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
FDA Recall
Terminated
·Merz Aesthetics, Inc.·Product code FMI·December 16, 2011
MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.
FDA Recall
Terminated
·Merz Aesthetics, Inc.·Product code LMH·August 18, 2011
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
FDA Recall
Terminated
·Merz North America, Inc.·Product code LMH·May 20, 2016
CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
FDA Recall
Open, Classified
·Zeltiq Aesthetics, Inc·Product code OOK·June 9, 2022
CoolFit ZELTIQ Vacuum Applicator REF BRZ-AP1-066-000
FDA Recall
Open, Classified
·Zeltiq Aesthetics, Inc·Product code OOK·June 9, 2022
CoolCurve ZELTIQ Vaccum Applicator REF BRZ-AP1-062-000
FDA Recall
Open, Classified
·Zeltiq Aesthetics, Inc·Product code OOK·June 9, 2022
CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
FDA Recall
Open, Classified
·Zeltiq Aesthetics, Inc·Product code OOK·June 9, 2022
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
FDA Recall
Open, Classified
·Zeltiq Aesthetics, Inc·Product code OOK·June 9, 2022
Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
FDA Recall
Terminated
·Merz Aesthetics, Inc.·Product code LMH·April 6, 2011
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
FDA Recall
Open, Classified
·Merz North America, Inc.·Product code LNM·September 30, 2020
Cellfina Prep Pack, Part No. CP1
FDA Recall
Terminated
·Ulthera Inc·Product code OUP·November 14, 2016
Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
FDA Recall
Terminated
·Merz North America, Inc.·Product code LMH·October 26, 2015