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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.

Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code LPH·February 17, 2006

JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254, QTY: (1), STERILE EO, SMITH & NEPHEW, INC. MEMPHIS, TN 38116

FDA Recall
Terminated ·Smith & Nephew Inc·Product code HSX·January 23, 2009

CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code JQC·August 17, 2009

Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.

FDA Recall
Terminated ·Sorin Group USA, Inc.·Product code DWF·December 30, 2009

Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.

FDA Recall
Terminated ·Pointe Scientific, Inc.·Product code CIC·November 10, 2009

DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code LRO·December 9, 2009

Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.

FDA Recall
Terminated ·Pointe Scientific, Inc.·Product code CIC·November 10, 2009

Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports and OPTION-LOK, 15 drops/mL; a sterile Rx single patient device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 160080401, list number 16008-01.

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·November 24, 2009

Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation

FDA Recall
Terminated ·Baxa Corporation·Product code KPE·November 12, 2009

AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

FDA Recall
Terminated ·AGA Medical Corporation·Product code DQY·December 18, 2009