BEUDAMED
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    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

    FDA Recall
    Terminated ·Insight Instruments, Inc.·Product code HNJ·June 27, 2013

    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

    Eye surgery stretcher with crank fowler, model 1069 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: A stretcher used for eye surgery.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010

    Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S) Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended use: Service parts are replacement parts for the eye surgery stretcher.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010

    Venoscope Neonatal Transilluminator, Model NT01

    FDA Recall
    Terminated ·Venoscope LLC·Product code HJN·April 28, 2005

    Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

    FDA Recall
    Terminated ·Oakworks Inc·Product code FNJ·April 21, 2022

    Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed

    FDA Recall
    Terminated ·Sunrise Medical CCG, Inc.·Product code FNJ·November 16, 2005

    Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FNJ·September 16, 2009

    Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FNJ·September 16, 2009

    Eye surgery stretcher with crank fowler, model 1079 Stryker Medical 3800 E. Centre Ave Portage MI 49002. Intended Use: A stretcher used for eye surgery.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNJ·February 26, 2010

    Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

    FDA Enforcement
    Class II ·Terminated·Halyard Health, Inc·April 25, 2018

    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 660 MID HN P20, CT OPTIMA 660 PRO, CT OPTIMA 660 PRO LONG BJG P2., CT OPTIMA 660 PRO MID, CT OPTIMA 660 PRO MID HN P20, CT OPTIMA 660S LNG HN P20, CT OPTIMA CT660 GT 1700, CT OPTIMA CT660 GT1700, CT OPTIMA CT660 GT1700V, CT OPTIMA CT660 PRO GT1700, CT OPTIMA CT660 PRO LNG P1.5 H, CT OPTIMA CT660 PRO MID P1.5 H, CT OPTIMA CT660 SE GT 1700, CT OPTIMA CT660 SE GT2000, CT660, CT660 ASIR OPT, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT1700 MKE25, OPT CT660 FREEDOM GT2000 MKE25, OPTI660_A_G_1.5, OPTI660_A_L_2.0, OPTI660_N_G_1.5, OPTI660_N_G_2.0, OPTI660_N_L_2.0, OPTIMA 660 DIVA, OPTIMA 660 LNG HN P20, OPTIMA 660 LNG HN P20, OPTIMA 660 LONG, OPTIMA 660 LONG BJG P2.0, OPTIMA 660 LONG WSO, OPTIMA 660 MID, OPTIMA 660 MID BJG P1.5, OPTIMA 660 MID HN P20, OPTIMA 660 MID HN P20, OPTIMA 660 MID WSO, OPTIMA 660 PRO LGN HN P20, OPTIMA 660 PRO LONG BJG P1.5_, OPTIMA 660 PRO LONG BJG P2, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG BJG P2.0, OPTIMA 660 PRO LONG WSO, OPTIMA 660 PRO MID BJG P1.5, OPTIMA 660 PRO MID BJG P2.0, OPTIMA 660 PRO MID H, OPTIMA 660 PRO MID HN P20, OPTIMA 660 PRO MID WSO, OPTIMA 660 WSO, OPTIMA 660S 32 OPTIMA 660S 32 SLICE LONG WSO, OPTIMA 660S 32 SLICE MID WSO, OPTIMA 660S LNG HN P20, OPTIMA 660S MID BJG P2.0, OPTIMA 660S PRO 32 SLICE M WSO, OPTIMA 660S PRO LONG BJG P2.0, OPTIMA 660S PRO MID BJG P1.5, OPTIMA 660S WSO, OPTIMA CT 660 FREEDOM, OPTIMA CT660, OPTIMA CT660 2ND EDITION, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR ADV 2ND, OPTIMA CT660 FREEDOM, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG BJG2.5, OPTIMA CT660 FREEDOM LG HN2, OPTIMA CT660 FREEDOM LG HN2.5, OPTIMA CT660 FREEDOM MD, OPTIMA CT660 FREEDOM MD BJG2., OPTIMA CT660 GS, OPTIMA CT660 GT 1700 BJG2, OPTIMA CT660 GT 1700 BJG2.5, OPTIMA CT660 GT 1700 HN P2, OPTIMA CT660 GT 1700 HN P2., OPTIMA CT660 GT 1700 HN P2.5, OPTIMA CT660 GT 2000 HN P2.5, OPTIMA CT660 GT1700, OPTIMA CT660 GT1700 MKE2.5, OPTIMA CT660 GT1700 PHASE 1.5, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000, OPTIMA CT660 GT2000 PHASE 1.5, OPTIMA CT660 LITE, OPTIMA CT660 LITE HN P2.5, OPTIMA CT660 MID P1.5 HINO, OPTIMA CT660 MID P20, OPTIMA CT660 MID P2000, OPTIMA CT660 PRO, OPTIMA CT660 PRO GT 2000, OPTIMA CT660 PRO GT1700, OPTIMA CT660 PRO GT1700 ASIR, OPTIMA CT660 PRO GT1700 P20, OPTIMA CT660 PRO GT1700 PHASE, OPTIMA CT660 PRO GT1700 PHASE 1.5, OPTIMA CT660 PRO GT1700V, OPTIMA CT660 PRO GT1700V ASIR, OPTIMA CT660 PRO GT2000, OPTIMA CT660 PRO GT2000 PHASE, OPTIMA CT660 PRO GT2000 PHASE 1.5, OPTIMA CT660 PRO LNG, OPTIMA CT660 PRO LNG P1.5, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LNG P1.5 HINO, OPTIMA CT660 PRO LONG BJG P2.0, OPTIMA CT660 PRO LONG P2.0, OPTIMA CT660 PRO MID P1.5, OPTIMA CT660 PRO MID P1.5 H, OPTIMA CT660 PRO MID P1.5 HINO, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700 BJG, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 BJG2.5, OPTIMA CT660 SE GT 1700 HN2, OPTIMA CT660 SE GT 2000, OPTIMA CT660 SE GT 2000 BJG, OPTIMA CT660 SE GT 2000 BJG2., OPTIMA CT660 SE GT 2000 BJG2.5, OPTIMA CT660 SE GT 2000 HN2, OPTIMA CT660 SE GT 2000 HN2.5, OPTIMA CT660 SE GT2000 MKE2.5, OPTIMA CT660 SE WITH ASIR, OPTIMA CT660 W/PRO PKG-BR, OPTIMA CT660 W/PRO PKG-LA, OPTIMA CT660-64 USA, OPTIMA CT660S, OPTIMA CT660S, OPTIMA CT660S 32 SLICE GT1700, OPTIMA CT660S 32 SLICE HINO, OPTIMA CT660S GT, OPTIMA CT660S GT 1700 HN2.5, OPTIMA CT660S GT 2000, OPTIMA CT660S GT 2000 BJG2.5, OPTIMA CT660S GT 2000 HN2.5, OPTIMA CT660S GT1700 BJG P2.5, OPTIMA CT660S GT1700 HN P2.5, OPTIMA CT660S PRO 32 HINO, OPTIMA CT660S PRO 32 SLICE, OPTIMA CT660S PRO 32 SLICE GT2, OPTIMA CT660S PRO P1.5 HINO, OPTIMACT660_A_G, OPTIMACT660_A_L, OPTIMACT660_N_G, OPTIMACT660_N_L, REVOLUTION EVO, REVOLUTION EVO WITH GT2000 TABLE (H

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Recall
    Terminated ·Linde Gas North America Llc 575 Mountain Ave Attn Import Compliance Manager New Providence NJ 07974·Product code CAN·March 8, 2013

    GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA 660 M40 3.5 LONG BJG, CT OPTIMA 660 M40 GT1700, CT OPTIMA 660 M40 GT1700 BEIJI, CT OPTIMA 660 M40 GT1700 HINO, CT OPTIMA 660 M40 GT2000 BEIJI, CT OPTIMA 660 M40 GT2000 HINO, CT OPTIMA CT 660, CT OPTIMA CT660, CT OPTIMA CT660 M4, CT OPTIMA CT660 M40, CT REVOLUTION EVO 3.5 LONG HIN, CT REVOLUTION EVO VT2000 HINO, CT660 MAR UPGRADE, MOBILE OPTIMA CT 660, OPTI660_A_G_2.0, OPTI660_M40_G, OPTI660_M40_L, OPTIMA 660, OPTIMA 660 128 FOR TW- DIRECT, OPTIMA 660 GT2000 M40 HINO MULTISLICE, OPTIMA 660 M40, OPTIMA 660 M40, OPTIMA 660 M40 3.5 HVY BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG BJG, OPTIMA 660 M40 3.5 LONG HINO, OPTIMA 660 M40 3.5 MID, OPTIMA 660 M40 3.5 MID BJG, OPTIMA 660 M40 3.5 MID HINO, OPTIMA 660 M40 3.5/6, OPTIMA 660 M40 3.5/6 HVY BJG, OPTIMA 660 M40 3.5/6 HVY HINO, OPTIMA 660 M40 3.5/6 HVY WAUK, OPTIMA 660 M40 3.5/6 LONG, OPTIMA 660 M40 3.5/6 LONG B, OPTIMA 660 M40 3.5/6 LONG BJG, OPTIMA 660 M40 3.5/6 LONG HINO, OPTIMA 660 M40 3.5/6 LONG WAUK, OPTIMA 660 M40 3.5/6 MID BJ, OPTIMA 660 M40 3.5/6 MID BJG, OPTIMA 660 M40 3.5/6 MID HI, OPTIMA 660 M40 3.5/6 MID HINO, OPTIMA 660 M40 3.5/6 MID WA, OPTIMA 660 M40 3.5/6 MID WAUK, OPTIMA 660 M40 GT1700, OPTIMA 660 M40 GT1700 BEIJING, OPTIMA 660 M40 GT1700 HINO, OPTIMA 660 M40 GT1700 WAUK, OPTIMA 660 M40 GT2000 B, OPTIMA 660 M40 GT2000 BEIJI, OPTIMA 660 M40 GT2000 BEIJING, OPTIMA 660 M40 GT2000 HINO, OPTIMA 660 M40 GT2000 WAUK, OPTIMA 660 M40 MOBILE BEIJING, OPTIMA CT 660, OPTIMA CT660 ASIR, OPTIMA CT660 ASIR 128 M RU, OPTIMA CT660 FREEDOM MD HN2, OPTIMA CT660 M40 GT1700, OPTIMA CT660 M40 GT2000, OPTIMA CT660 M40 GT2000 BEIJIN, OPTIMA CT660 M40 GT2000 HINO, OPTIMA CT660 P2.5, OPTIMA CT660 P25 UPG KIT, OPTIMA CT660 PRO MID, OPTIMA CT660 SE, OPTIMA CT660 SE GT 1700, OPTIMA CT680, OPTIMA CT680 KL64 GT1700 BHW, REVOLUTION EVO, REVOLUTION EVO 3.5 HVY BJG, REVOLUTION EVO 3.5 HVY HINO, REVOLUTION EVO 3.5 HVY WAUK, REVOLUTION EVO 3.5 LONG BJG, REVOLUTION EVO 3.5 LONG HINO, REVOLUTION EVO 3.5 LONG WAUK, REVOLUTION EVO 3.5 MID BJG, REVOLUTION EVO 3.5 MID HINO, REVOLUTION EVO 3.5 MID WAUK, REVOLUTION EVO 3.5MID HINO CT, REVOLUTION EVO 3.6 CHN HINO, REVOLUTION EVO 3.6 HVY BJG, REVOLUTION EVO 3.6 HVY HINO, REVOLUTION EVO 3.6 HVY WAUK, REVOLUTION EVO 3.6 LONG, REVOLUTION EVO 3.6 LONG BJG, REVOLUTION EVO 3.6 LONG HIN, REVOLUTION EVO 3.6 LONG HINO, REVOLUTION EVO 3.6 LONG WAUK, REVOLUTION EVO 3.6 MID BJG, REVOLUTION EVO 3.6 MID HINO, REVOLUTION EVO 3.6 MID WAUK, REVOLUTION EVO 3.6B, REVOLUTION EVO 3.6B HVY HINO, REVOLUTION EVO 3.6B LONG, REVOLUTION EVO 3.6B LONG BJG, REVOLUTION EVO 3.6B LONG HINO, REVOLUTION EVO 3.6B MID BJG, REVOLUTION EVO 3.6B MID HINO, REVOLUTION EVO GT1700, REVOLUTION EVO GT2000, REVOLUTION EVO GT2000 HINO, REVOLUTION EVO GT2000X (HINO), REVOLUTION EVO GT2000X HINO, REVOLUTION EVO VT1700 BEIJING, REVOLUTION EVO VT1700 HINO, REVOLUTION EVO VT1700 WAUK, REVOLUTION EVO VT2000 BEIJING, REVOLUTION EVO VT2000 HINO, REVOLUTION EVO VT2000 WAUK, REVOLUTION EVO VT2000X BEIJING, REVOLUTION EVO VT2000X HINO, REVOLUTION EVO VT2000X WAUK, REVOLUTION EVO WITH GT1700V TA, REVOLUTION EVO WITH GT2000 TAB

    FDA Enforcement
    Class II ·Terminated·GE Healthcare Japan Corporation·August 29, 2018