Browse Device Recalls
797 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 797 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 797 FDA device recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 15, 2024 | Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 ... | 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: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 80... | 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 Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450... | 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: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: ... | 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 SATINSLIT FULL HANDLE3.0MM 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 Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalo... | 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: Alcon Custom Pak Model/Catalog Number: Many Software Version:... | 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: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 ... | 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: 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 |
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.