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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.

BD Exacta 6Fr Percutaneous Sheath Introducer Tray.

FDA Recall
Terminated ·Becton Dickinson Infusion Therapy·Product code DYB·January 10, 2005

Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir.

FDA Recall
Terminated ·Hospira Inc.·Product code DQO·November 2, 2004

ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

FDA Recall
Terminated ·Diasorin Inc.·Product code LAZ·October 20, 2004

Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8048, 8060, 8075

FDA Recall
Terminated ·Boston Scientific·Product code MTD·February 14, 2005

Catheterization Kits containing Angiographic Syringes with rotator connector.

FDA Recall
Terminated ·Hospira Inc.·Product code DQO·November 2, 2004

The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191.

FDA Recall
Terminated ·Proctor & Gamble Co·Product code JEQ·February 23, 2005

Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

FDA Recall
Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code NIK·February 9, 2005

The product is a battery operated toothbrush. Spinbrush Pro Ex Soft battery operated toothbrushes UPC 76687800078

FDA Recall
Terminated ·Proctor & Gamble Co·Product code JEQ·February 23, 2005

Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·January 14, 2005

Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

FDA Recall
Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005