Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls in TX.

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DateProductReasonClassFirm
Jul 15, 2024 Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 806... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
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
Jul 15, 2024 Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog N... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Ca... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
Jul 15, 2024 Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 ... Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... Class II Alcon Research LLC
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
Jul 2, 2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier,... Class II Argon Medical Devices, Inc
Jun 14, 2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains in... Class II Argon Medical Devices, Inc
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
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Deep brain stimulation system will first turn off after approximately 50 days after the system is... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
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
Mar 18, 2024 LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019,... Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to ... Class II XENEX Disinfection Services Inc.
Mar 15, 2024 Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. Class II Alcon Research, LLC
Feb 21, 2024 SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pa... Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be br... Class II Alcon Research, LLC
Feb 8, 2024 Chromophare Surgical Light System , REF CH00000001 Due to insufficient mounting force the stability of surgical light system cannot be guaranteed. Class II Stryker Communications
Feb 5, 2024 EasyPoint Needle, 25G x 5/8", REF: 82091 The needle cannula of a retractable needle may detach from the needle holder in the patient. Class II Retractable Technologies, Inc.
Dec 19, 2023 Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD ... Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to ... Class II OriGen Biomedical, Inc.
Nov 10, 2023 DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 L... Due to incorrect product/device within packaging. Class II Encore Medical, LP

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.