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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.
Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Panta Nail, Rx only, Sterile,
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HSB·March 3, 2017
Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HSB·February 28, 2017
Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g) Poly Component Trial - PS 5x10, REF 90-SRK-180510 h) Poly Component Trial - PS 5x12, REF 90-SRK-180512 i) Poly Component Trial - PS 5x14, REF 90-SRK-180514 j) Poly Component Trial - PS 6x10, REF 90-SRK-180610 k) Poly Component Trial - PS 6x12, REF 90-SRK-180612 l) Poly Component Trial - PS 6x14, REF 90-SRK-180614 The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·February 20, 2017
Regard, Item Number: 800508003, Sterile, LD0586C - C Section - Jasper
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa
FDA Recall
Terminated
·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 23, 2017
Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
FDA Recall
Terminated
·Stanley Security Solutions Inc·Product code ILQ·June 22, 2016