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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.

Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

FDA Recall
Terminated ·The Raymond Corporation S Canal·Product code RER·November 28, 2011

SideWinder Hip Wand Product Number AC2340-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures

FDA Recall
Terminated ·Innovatech Medical Resources L.P.·August 8, 2011

SoftReports versions 1.1.6.x and 1.1.7.x SoftReports version 1.1.6 released 2/2008; Version 1.1.7 released 6/2008. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftReports is a report designer and web-based report launching tool to be used by knowledgeable, trained, and experienced personnel. It provides the ability to create ad hoc, user defined queries, and reports using data from other SCC products. SoftReports enables users to customize standard reports generated by SCC systems to meet their specific needs. This system performs the following functions: 1. The ability to customize report layouts using beginner, intermediate, or advanced options. 2. The ability to import and export reports. 3. The ability to provide custom desktops to launch SQL's within other SCC applications. 4. The ability to preview and modify layouts specific to users' needs. 5. The ability to modify elements of reports using the comprehensive control formatting toolbar. 6. The ability to incorporate charts and graphics into reports. 7. The ability to modify existing query templates. 8. The ability to create independent and embedded queries. 9. The ability to pars SQL statements and notify users of errors within the syntax. 10. The ability to easily update criteria parameters to indicate input needed for executing queries. 11. The ability to view and print any report that is created using the Designer. 12. The ability to schedule, execute, and track ad-hoc reports. This system does not perform the following functions: 1. SoftReports is not configured to write back to the database. 2. SoftReports does not support user-created Ad Hoc reports being used for diagnostic purposes. 3. SoftReports is not intended to alter the meaning of patient result reports (test reports).

FDA Recall
Terminated ·SCC Soft Computer·Product code LNX·June 23, 2010

Pulmonary Valve & Conduit SG Used in heart surgery

FDA Recall
Terminated ·CryoLife, Inc.·Product code MIE·January 7, 2011

Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.

FDA Recall
Terminated ·Fresenius Medical Care Holdings, Inc.·January 19, 2011

XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

FDA Recall
Terminated ·Computerized Medical Systems Inc·Product code muj·September 10, 2010

Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator. Amstech Incorporated, Alpharetta, GA 30022. Targeting, detecting heated areas, searches.

FDA Recall
Terminated ·Amstech Incorporated·Product code REP·August 17, 2010

Fungitell STAT- IVD Assay for (1 3)-~-D-Glucan in Serum Ref: FT007

FDA Recall
Terminated ·Associates of Cape Cod, Inc.·Product code NQZ·August 17, 2022

Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control

FDA Recall
Terminated ·Oridion Medical·Product code cck·May 26, 2010

Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, Stryker Instuments, Kalamazoo, MI, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code cac·November 12, 2009