BEUDAMED
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    Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following product is being recalled: "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)" / Material Description / Catalog Number. M001314001 M001314000 IMAGER II/5/ST/65/038 BX5 31-400 M001314011 M001314010 IMAGER II/5/ST/100/038 BX5 31-401 M001314021 M001314020 IMAGER II/5/ST/65/035 BX 5 31-402 M001314031 M001314030 IMAGER II/5/ST/100/035 BX 5 31-403 M001314041 M001314040 IMAGER II/5/BARNH/100/038 BX5 31-404 M001314051 M001314050 IMAGER II/5/BERN/100/038 BX5 31-405 M001314061 M001314060 IMAGER II/5/BERN/100/035 BX 5 31-406 M001314071 M001314070 IMAGER II/5/BERN/40/035 BX 5 31-407 M001314081 M001314080 IMAGER II/5/BERN/40/038 BX5 31-408 M001314091 M001314090 IMAGER II/5/BERN/65/035 BX 5 31-409 M001314101 M001314100 IMAGER II/5/BERN/65/038 BX5 31-410 M001314111 M001314110 IMAGER II/5/WEIN/100/038 BX5 31-411 M001314121 M001314120 IMAGER II/5/WEIN/100/035 BX 5 31-412 M001314131 M001314130 IMAGER II/5/H1/65/038 BX5 31-413 M001314141 M001314140 IMAGER II/5/H1/100/038 BX5 31-414 M001314151 M001314150 IMAGER II/5/H1/100/035 BX 5 31-415 M001314161 M001314160 IMAGER II/5/H3/100/038 BX5 31-416 M001314171 M001314170 IMAGER II/5/H3/100/035 BX 5 31-417 M001314181 M001314180 IMAGER II/5/H1H/100/038 BX5 31-418 M001314191 M001314190 IMAGER II/5/H1H/100/035 BX 5 31-419 M001314201 M001314200 IMAGER II/5/H3H/100/035 BX 5 31-420 M001314211 M001314210 IMAGER II/5/JB1/65/038 BX5 31-421 M001314221 M001314220 IMAGER II/5/JB1/100/038 BX5 31-422 M001314231 M001314230 IMAGER II/5/JB1/100/035 BX 5 31-423 M001314241 M001314240 IMAGER II/5/JB2/100/038 BX5 31-424 M001314251 M001314250 IMAGER II/5/JB2/100/035 BX 5 31-425 M001314261 M001314260 IMAGER II/5/JB3/100/038 BX5 31-426 M001314271 M001314270 IMAGER II/5/JB3/100/035 BX 5 31-427 M001314281 M001314280 IMAGER II/5/MAN/100/038 BX5 31-428 M001314291 M001314290 IMAGER II/5/MAN/100/035 BX 5 31-429 M001314301 M001314300 IMAGER II/5/SIM1/65/038 BX5 31-430 M001314311 M001314310 IMAGER II/5/SIM1/65/035 BX 5 31-431 M001314321 M001314320 IMAGER II/5/SIM1/100/038 BX5 31-432 M001314331 M001314330 IMAGER II/5/SIM1/100/035 BX 5 31-433 M001314341 M001314340 IMAGER II/5/SIM2/100/038 BX5 31-434 M001314351 M001314350 IMAGER II/5/SIM2/100/035 BX 5 31-435 M001314361 M001314360 IMAGER II/5/SIM3/100/038 BX5 31-436 M001314371 M001314370 IMAGER II/5/SIM3/100/035 BX 5 31-437 M001314381 M001314380 IMAGER II/5/SIM4/100/038 BX5 31-438 M001314391 M001314390 IMAGER II/5/HN1/100/038 BX5 31-439 M001314401 M001314400 IMAGER II/5/HN1/100/035 BX 5 31-440 M001314411 M001314410 IMAGER II/5/HN2/100/038 BX5 31-441 M001314421 M001314420 IMAGER II/5/HN2/100/035 BX 5 31-442 M001314431 M001314430 IMAGER II/5/HN3/100/038 BX5 31-443 M001314441 M001314440 IMAGER II/5/HN3/100/035 BX 5 31-444 M001314451 M001314450 IMAGER II/5/HN4/100/038 BX5 31-445 M001314461 M001314460 IMAGER II/5/HN4/100/035 BX 5 31-446 M001314471 M001314470 IMAGER II/5/HN5/100/038 BX5 31-447 M001314481 M001314480 IMAGER II/5/HN5/100/035 BX 5 31-448 M001314491 M001314490 IMAGER II/5/CK/100/035 BX 5 31-449 M001314501 M001314500 IMAGER II/5/GEN/100/035 BX 5 31-450 M001314511 M001314510 IMAGER II/5/GEN+2 SIDEHOLES/100/035 BX 5 31-451 M001314521 M001314520 IMAGER II/5/CHGB/65/038 BX5 31-452 M001314531 M001314530 IMAGER II/5/CHGB/65/035 BX 5 31-453 M001314541 M001314540 IMAGER II/5/CHGC/65/038 BX5 31-454 M001314551 M001314550 IMAGER II/5/CHGC/65/035 BX 5 31-455 M001314561 M001314560 IMAGER II/5/CHG2.5/65/038 BX5 31-456 M001314571 M001314570 IMAGER II/5/CHG2.5/65/035 BX 5 31-457 M001314581 M001314580 IMAGER II/5/CONTRA 2/65/038 BX5 31-458 M001314591 M001314590 IMAGER II/5/CONTRA 2/65/035 BX 5 31-459 M001314611 M001314610 IMAGER II/5/DUCK/65/035 BX 5 31-4

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQO·March 15, 2012

    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·June 13, 2018

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    AF 550 x 5ML/H FH DL 30hole SAT C,4"IN, Product code MC0050XLYK2 CP, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. Rx only. Sterilized using ethylene oxide. Manufacturer: Medtronic CryoCath LP, Kirkland, Quebec H9H 5H3, Canada. Product Usage: The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DRA·July 15, 2011

    Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code OAE·August 29, 2011

    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.

    FDA Enforcement
    Class II ·Terminated·Vapotherm, Inc.·October 1, 2014

    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.

    FDA Recall
    Terminated ·Ethicon, Inc US·Product code HIH·December 16, 2004

    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. They are used, in combination with endoscopic accessories, for examination, diagnosis, and/or therapy in various medical disciplines such as urology and gynecology.

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code HIH·May 23, 2019

    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013

    CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HIH·April 9, 2020

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013

    Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripheral blood vessels. They are designed for Single Use.

    FDA Recall
    Terminated ·Mizuho America, Inc.·Product code HCH·October 10, 2013