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Sources: EU EUDAMED, US FDA
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FDA Recall
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CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code LPN·June 23, 2022
B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYB·May 8, 2006
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
FDA Recall
Terminated
·Alivecor SFO·Product code DXH·January 9, 2015
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Recall
Completed
·Townsend Design·Product code IQI·September 23, 2023
STERIS 4085, 5085 & 5085SRT Surgical Tables
FDA Recall
Terminated
·Steris Corporation·Product code FQO·May 14, 2010
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
FDA Recall
Terminated
·Steris Corporation·Product code FQO·June 27, 2014
Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.
FDA Recall
Terminated
·Stryker Communications Corp·Product code FQO·September 2, 2008
Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
FDA Recall
Terminated
·Maquet Medical Systems, Usa·Product code FQO·April 13, 2012
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
FDA Recall
Terminated
·Draeger Medical, Inc.·Product code FQO·September 30, 2013
TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.
FDA Recall
Terminated
·Berchtold Corp.·Product code FQO·September 23, 2015
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FQO·June 10, 2015
Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FQO·March 28, 2016
IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018
IMRIS ORT300 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
FDA Recall
Terminated
·Deerfield Imaging, Inc.·Product code FQO·February 23, 2018
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
FDA Recall
Terminated
·Helena Laboratories, Corp.·Product code GFO·January 5, 2021
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 14, 2022
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.
FDA Recall
Open, Classified
·MAQUET GMBH Kehler Str. 31 Rastatt Germany·Product code FQO·July 14, 2025
OR table TITAN U, Surgical Table. Surgical bed with Orthopedic Accessories.
FDA Recall
Terminated
·Trumpf Medical Systems, Inc.·Product code FQO·January 21, 2011