Browse Device Recalls

39 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 39 FDA device recalls.

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DateProductReasonClassFirm
Jun 28, 2023 Alcon Custom Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Phaco Standalone Tips Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Infinity FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Constellation Procedure Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Legion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Jun 28, 2023 Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-... Class II Alcon Research, LTD.
Aug 28, 2018 CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... Class I Alcon Research, LTD.
Aug 28, 2018 CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065... Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... Class I Alcon Research, LTD.
Aug 28, 2018 CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT,... Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... Class I Alcon Research, LTD.
Aug 28, 2018 CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF C... Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micr... Class I Alcon Research, LTD.
Jan 12, 2018 Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c... Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... Class II Alcon Research, LTD.
Jan 12, 2018 Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c... Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... Class II Alcon Research, LTD.
Aug 8, 2017 Alcon Custom Pak Alcon is initiating a medical device recall, after receiving notification from a supplier of a re... Class II Alcon Research, LTD.
Jun 30, 2017 ORA System with VerifEye, Catalog Number 8065998300 For use during intraocul... Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... Class II Alcon Research, Ltd.
Jun 30, 2017 ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during int... Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract su... Class II Alcon Research, Ltd.
May 25, 2017 LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmi... Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the micros... Class II Alcon Research, Ltd.
Mar 27, 2017 Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblag... Alcon is initiating a Voluntary Medical Device Removal because the product supplier has stated th... Class II Alcon Research, Ltd.
Sep 5, 2016 Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySo... The intraocular lens could become lodged within the cartridge Class II Alcon Research, Ltd.
Jul 28, 2016 Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Al... The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that coul... Class II Alcon Research, Ltd.
Jul 28, 2016 LAUREATE World Phaco System Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) Class II Alcon Research, Ltd.
May 24, 2016 CENTURION Vision System The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment ... Class II Alcon Research, Ltd.
Apr 28, 2016 CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision Syst... Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS ... Class II Alcon Research, Ltd.
Apr 14, 2016 LenSx Laser System. Indicated for use in patients undergoing cataract surger... Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after rec... Class II Alcon Research, Ltd.
Mar 1, 2016 VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Gu... Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision P... Class II Alcon Research, Ltd.
Sep 29, 2015 Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric... Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ ... Class I Alcon Research, Ltd.
Sep 21, 2015 Custom Pak 9319-27. Single-use medical devices and accessories designed by m... The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than th... Class II Alcon Research, Ltd.
Aug 11, 2015 LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue... Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports... Class II Alcon Research, Ltd.
Aug 11, 2015 Alcon 23G and 25G Valved Entry System provides access into the posterior segm... The product has potential to leak beyond their design specification. Class II Alcon Research, Ltd.
Aug 11, 2015 Custom Paks containing 23G and 25G valved trocar cannula provide access into ... The product has potential to leak beyond their design specification. Class II Alcon Research, Ltd.
Aug 11, 2015 23G and 25G Constellation Totalplus Paks provides access into the posterior s... The product has potential to leak beyond their design specification. Class II Alcon Research, Ltd.
Jun 2, 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... Insufficient seal on the outside packaging, potentially affecting the sterility of the product. Class II Alcon Research, Ltd.
Apr 28, 2015 The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use... The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves d... Class II Alcon Research, Ltd.
Apr 15, 2015 ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS... There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) ... Class I Alcon Research, Ltd.
Nov 11, 2014 Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ... The product is sold and labeled as EO sterilized, however the units were not sterilized prior to ... Class II Alcon Research, Ltd.
Oct 30, 2014 INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. S... Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in t... Class II Alcon Research, Ltd.
Oct 6, 2014 INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718... The recalling firm received complaints related to leakage from the tubing near the white luer of ... Class II Alcon Research, Ltd.
Jun 3, 2014 eye-pak 7407 Tray Support Cover REF 8065740745 The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot... Class II Alcon Research, Ltd.
May 16, 2014 Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Numbe... Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actua... Class II Alcon Research, Ltd.
May 29, 2012 This voluntary medical device correction is related to Alcon products that pr... This medical device correction is related to Alcon products that present a 23G non-valved trocar ... Class II Alcon Research, LTD.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.