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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.

Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216

FDA Recall
Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FKX·May 29, 2019

14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code LFJ·March 13, 2019

EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code KNW·May 2, 2019

APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code JQP·September 7, 2018

TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code MBH·August 19, 2019

The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.

FDA Recall
Terminated ·LeMaitre Vascular, Inc.·Product code MJN·July 24, 2019

SonarMed AirWave Monitor, Model Number M0001

FDA Recall
Terminated ·SonarMed Inc·Product code OQU·April 17, 2017

Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

FDA Recall
Terminated ·Spacelabs Healthcare Inc·Product code MHX·October 18, 2016

Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027

FDA Recall
Terminated ·Hospira Inc.·Product code FRN·February 5, 2013

Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.

FDA Recall
Terminated ·Azer Scientific, Inc.·Product code MRV·August 24, 2016