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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.

Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio/INRatio2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that initiate coagulation. When the blood clots, changes in impedance in the sample are detected by the monitor. The monitor calculates the PT and INR results from this impedance change and reports them on the display. The Alere INRatio/INRatio2 PT/INR Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for use outside the body (in vitro diagnostic use). The Alere INRatio/INRatio2 PT/INR Monitoring System is intended for professional and home use by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio/INRatio2 PT/INR Monitoring System is not intended to be used for screening purposes.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

FDA Recall
Terminated ·Avid Medical, Inc.·Product code LRO·October 5, 2015

Convenience Kits, MOHS "OPENING" PROCEDURE TRAY

FDA Recall
Terminated ·Avid Medical, Inc.·Product code LRO·October 5, 2015

Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

FDA Recall
Terminated ·Medtronic·Product code GEI·July 8, 2016

Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purpose.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code GJS·July 11, 2016

Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable

FDA Recall
Terminated ·Medtronic·Product code GEI·July 8, 2016

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

FDA Recall
Terminated ·LeMaitre Vascular, Inc.·Product code MGZ·August 3, 2016

ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·July 13, 2016

AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

FDA Recall
Terminated ·Ab Sciex·Product code DOP·June 16, 2016

Standard Abutment Transfer Coping Dental implants

FDA Recall
Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015