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Browse Device Recalls

58 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 58 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 58 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
May 23, 2024 Surgical Image Guidance Functionality, software used with NGENUITY 3D Visuali... After surgery initiation, while using surgical image guidance, if significant eye rotation/moveme... Class II Alcon Research LLC
Apr 22, 2024 ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 806592... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Apr 22, 2024 ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Apr 22, 2024 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Apr 22, 2024 ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Apr 17, 2020 Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYL... Incorrect IOL diopter Class II Alcon Research LLC
Jul 25, 2018 Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Pro... There was a potential that a 25-gauge infusion cannula may be included within the procedure pak i... Class II Alcon Research LLC

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.