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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.

NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code MKJ·January 28, 2013

NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices

FDA Recall
Terminated ·Codman & Shurtleff, Inc.·Product code DQY·January 11, 2013

Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545

FDA Recall
Terminated ·Ethicon Endo-Surgery Inc·Product code GEI·November 6, 2012

GE Healthcare Definium 5000 / 5220493 X-Ray System

FDA Recall
Terminated ·GE Healthcare, LLC·Product code JAC·September 26, 2012

Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 18, 2012

Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·October 24, 2012