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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.

CoCr Head (Not distributed in the United States) Used in total hip replacement.

FDA Recall
Terminated ·Zimmer, Inc.·Product code LPH·August 30, 2013

Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LON·August 21, 2013

Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LON·August 21, 2013

Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

FDA Recall
Terminated ·Villa Radiology Systems LLC·Product code KXJ·August 2, 2013

AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is generally attached to the patients upper and lower molars or bicuspids by means of temporary stainless steel crowns or orthodontic bands. Retainer, Screw Expansion, Orthodontic.

FDA Recall
Terminated ·Sybron Dental Specialties·Product code DYJ·June 6, 2013

Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LON·August 21, 2013

Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices

FDA Recall
Terminated ·Covidien LLC·Product code NGT·August 16, 2013

DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

FDA Recall
Terminated ·DeVilbiss Healthcare LLC·Product code JCX·March 7, 2013

Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

FDA Recall
Terminated ·Atrium Medical Corporation·Product code DSY·July 12, 2013

GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSZ·August 28, 2013