SEO landing
FDA Medical Device Recalls
View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.
Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FDA Recall
Terminated
·Teleflex Medical·Product code CCT·October 27, 2016
Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a patients anatomy with high quality images and a large field-of-view in both two and three dimensions
FDA Recall
Terminated
·Medtronic Navigation, Inc.-Littleton·Product code OWB·September 22, 2016
Regard, Item Number: 800553002, Sterile, OR0642B - Total Knee - Medical Center Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
FDA Recall
Terminated
·Ohmeda Medical·Product code FMZ·November 18, 2016
Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code JQP·March 1, 2017
Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017