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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.

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Recall
Terminated ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·June 27, 2018

Reprocessed HARMONIC Ace +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand controls button.

FDA Recall
Terminated ·Stryker Sustainability Solutions·Product code NLQ·May 8, 2018

PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688

FDA Recall
Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM

FDA Recall
Open, Classified ·COVIDIEN MEDTRONIC·Product code GDW·May 22, 2018

PRONOVA SUTURE BLUE 122CM M1.5, D10189

FDA Recall
Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000

FDA Recall
Terminated ·Abbott Laboratories, Inc.·Product code MOM·June 14, 2018

PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844

FDA Recall
Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018

Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM

FDA Recall
Open, Classified ·COVIDIEN MEDTRONIC·Product code GDW·May 22, 2018

Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 30, 2018

Microintroducer Kit, 5F, Tearaway Sheath/Dilator PG, Catalog Number 45-901

FDA Recall
Terminated ·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code DYB·May 10, 2018