87 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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VACLOCK Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code FMF·October 22, 2010
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
FDA Recall
Terminated
·Dexcom Inc·Product code MDS·July 12, 2019
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
FDA Recall
Terminated
·Organ Recovery Systems, Inc.·Product code KDL·December 14, 2016
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWA·June 3, 2014
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MLR·January 23, 2012
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWA·June 3, 2014
GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit.
FDA Recall
Terminated
·GE Healthcare Integrated IT Solutions·Product code HGM·June 30, 2008
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Recall
Terminated
·DePuy Orthopaedics, Inc.·Product code KWA·June 3, 2014
AirTouch F20 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation
FDA Recall
Terminated
·Carefusion 2200 Inc
1500 S Waukegan Rd
Mpwm Bldg.
Waukegan IL 60085-6728·Product code BTM·April 22, 2013
AirFit F20 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit N10 Nasal Masks and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit F30i Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirFit F30 Full Face Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
FDA Recall
Terminated
·Carefusion 303, Inc.·Product code FPA·April 20, 2011
Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alvarado II Base Plate and Foot Piece: Alvarado Foot Piece: Item Number: 00-1320-010-00 Alvarado Knee Holder Base Plate Assembly: Item Number: 00-1320-011-00 Alvarado II Foot Piece: Item Number: 00-1320-210-00 Alvarado II Base Plate: Item Number: 00-1320-211-00 Product Usage: This device is designed to hold the patient s knee in the selected position during surgery. The Alvarado Knee Holder includes a Base Plate assembly with two rows of slotted hooks. These rows extend upward from the base plate for a sufficient length to provide adequate selective adjustment. A Foot Piece is mounted on an alignment rod that is pivotally engaged into the hook portion of the slots.
FDA Recall
Terminated
·Zimmer Surgical Inc·Product code JEB·April 16, 2019
AirFit N20 Nasal Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Recall
Open, Classified
·Product code BZD·November 20, 2023