BEUDAMED
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    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Recall
    Open, Classified ·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023

    Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

    FDA Recall
    Terminated ·WOM World of Medicine AG Salzufer 8 Berlin Germany·Product code HIG·August 14, 2019

    ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·November 28, 2012

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·September 29, 2009

    AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)

    FDA Recall
    Terminated ·Abbott Medical Optics Inc (AMO)·Product code HQL·November 11, 2009

    Truform Therapeutic Classic Medical Style Compression Pantyhose 20-30 mmHG, A Div of SAI, Cincinnati, OH 45209 Product Usage: To help relieve tired, heavy legs, and moderate to pronounced varicose veins and swelling.

    FDA Recall
    Terminated ·Surgical Appliance Industries·Product code FQL·October 7, 2011

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·May 13, 2014

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    Tecnis Multifocal Silicone Posterior Chamber IOLs (Model: ZM900)

    FDA Recall
    Terminated ·Advanced Medical Optics, Inc.·Product code HQL·October 5, 2005

    iSert Intraocular Lens (Model PC-60AD)

    FDA Recall
    Terminated ·Hoya Surgical Optics, Inc.·Product code HQL·June 17, 2011

    Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc (AMO)·Product code HQL·September 20, 2011

    Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.

    FDA Recall
    Terminated ·Medicel Ag Luchton 1262 Wolfhalden Switzerland·Product code HQL·August 5, 2013

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.

    FDA Recall
    Terminated ·AMO Puerto Rico Manufacturing, Inc.·Product code HQL·January 28, 2014

    UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106, 1167141106, 1167151106, 1167161106, 1167171106, 1167181106, 1167191106, 1167201106, 1167211106, 1167221106, 1167231106, 1167241106, 1167251106, 1167261106, 1167271106, 1167281106, 1167291106, 1167301106, 1167311106, 1167321106, 1167331106, 1167341106, 1167351106, 1167361106, 1167371106, 1167381106, 1167391106, 1167401106, 1167411106, 1167421106, 1167431106, 1167441106, 1167451106, 1167461106, 1167471106, 1167481106, 1167491106, 1167501106, 1167511106, 1167521106, 1167531106, 1167541106, 1167551106, 1167561106, 1167571106, 1167581106, 1167591106, 1167601106, 1167611106, 1167621106, 1167631106, 1167641106, 1167651106, 1167661106, 1167671106, 1167681106, 1167691106, 1167701106, 1167711106, 1167721106, 1167731106, 1167741106, 1167751106, 1167761106, 1167771106, 1167781106, 1167791106, 1167801106, 1167811106, 1167821106, 1167831106, 1167841006, 1167851106, 1167861106, 1167871106, 1167881106, 1167891106, 1167901106, 1167911106, 1167921106, 1167931106, 1167941106, 1167951106, 1167961106, 1167971106, 1167981106, 1167991106, 1168001106, 1168011106, 1168021106, 1168031106, 1168041106, 1168051106, 1168061106, 1168071106, 1168081106, 1168091106, 1168101106, 1168111106, 1168121106, 1168131106, 1168141106, 1168151106, 1168161106, 1168171106, 1168181106, 1168191106, 1168201106, 1168211106, 1168221106, 1168231106, 1168241106, 1168251106, 1168261106, 1168271106, 1168281106, 1168291106, 1168301106, 1168311106, 1168321106, 1168331106, 1168341106, 1168351106, 1168361106, 1168371106, 1168381106, 1168391106, 1168401106, 1168411106, 1168421106, 1168431106, 1168441106, 1168451106, 1168461106. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.

    FDA Recall
    Terminated ·Aaren Scientific, Incorporated·Product code HQL·August 2, 2011