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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.

GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems

FDA Recall
Terminated ·General Electric Medical Systems Information Technology·Product code DSI·November 8, 2007

PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741

FDA Recall
Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01 (Stryker Part #: 0100-224-131); Distributed by Stryker Communications, Flower Mound, TX 75028. (These cables are commonly used with the Switchpoint Infinity II)

FDA Recall
Terminated ·Stryker Communications·Product code GCJ·October 3, 2007

VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758.

FDA Recall
Terminated ·Product code JDK·September 19, 2007

PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741

FDA Recall
Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741

FDA Recall
Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741

FDA Recall
Terminated ·Oasis Medical Inc·Product code HNN·July 18, 2007

Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007

Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

FDA Recall
Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·November 15, 2007