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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.

Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 2, 2010

Abbott Diabetes Care, Precision Point of Care Blood Glucose Test Strips;

FDA Recall
Terminated ·Abbott Diabetes Care, Inc.·Product code NBW·December 22, 2010

Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028; Product is manufactured and distributed by Abaxis, Incorporated, Union City, CA The Piccolo Comprehensive Metabolic Reagent Disc, used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer, is intended to be used for the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen (BUN) in heparinized whole blood, heparinized plasma or serum. The patented selfcontained reagent rotors are bar coded, contain liquid diluents and dry reagents and use centrifugal and capillary technology to provide the most commonly requested chemistry panel results in approximately 12 minutes. The Piccolo Comprehensive Metabolic Panel, used with the Piccolo Blood Chemistry Analyzer is a diagnostic system that aids in disease diagnosis or monitoring disease treatment.

FDA Recall
Terminated ·Abaxis, Incorporated·Product code CKA·November 19, 2010

Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.

FDA Recall
Terminated ·Stryker Howmedica Osteonics Corp.·Product code MEH·August 2, 2010

Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.

FDA Recall
Terminated ·International Technidyne Corp.·Product code KQG·November 30, 2010

LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications

FDA Recall
Terminated ·GE Healthcare, LLC·Product code JAK·October 27, 2010

ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.

FDA Recall
Terminated ·Instrumentation Laboratory Co.·Product code JPA·November 11, 2010

ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.

FDA Recall
Terminated ·Instrumentation Laboratory Co.·Product code JPA·November 11, 2010

VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. Product Quantity Distributed (Int) 2540 units

FDA Recall
Terminated ·Carl Zeiss Meditec Inc·Product code EPT·May 18, 2009

Centurion Medical Products Port access tray DT7780, Sterile.

FDA Recall
Terminated ·Centurion Medical Products·Product code LRS·June 2, 2010