42 results
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51ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Recall
Terminated
·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Completed
·Lens.com·Product code LPM·August 14, 2018
Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Terminated
·Alcon Research LLC·Product code HQC·July 25, 2018
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Recall
Completed
·Allied Vision Group Inc·Product code LPM·August 1, 2018
Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable; Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Research, Ltd·Product code HNR·March 7, 2008
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code NGY·April 29, 2009
Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #2638-17, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #6515-51, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code HNN·December 22, 2006
Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code NGY·April 29, 2009
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code HQC·April 28, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code MLZ·April 28, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code LRO·November 24, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
FDA Recall
Open, Classified
·Alcon Research LLC·Product code HQE·August 5, 2025
LADARVision Excimer Laser System.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code LZS·August 1, 2005
PurePoint System Operator's Manual, Catalog Number 8065751131, Rev. B for use with the Alcon PurePoint Laser, Catalog Number 8065750597 Indicated for use in photocoagulation of both anterior and posterior segments of the eye.
FDA Recall
Terminated
·Alcon Laboratories, Inc.·Product code HQF·September 26, 2008
AcrySof ReSTOR Intraocular Lens
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code MFK·December 14, 2006
AcrySof ReSTOR Intraocular Lens
FDA Recall
Terminated
·Alcon Laboratories, Inc·Product code MFK·December 14, 2006