Browse Device Recalls
816 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 816 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 816 FDA device recalls in TX.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 18, 2024 | EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee T... | 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which m... | Class II | Encore Medical, LP |
| Dec 12, 2024 | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburs... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 12, 2024 | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Ther... | Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanicall... | Class II | LivaNova USA, Inc. |
| Dec 10, 2024 | EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new... | Class II | Encore Medical, LP |
| Nov 13, 2024 | Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Cat... | Increase in complaints associated with a molding defect within the inner lumen of delivery cartri... | Class II | Alcon Research LLC |
| Nov 5, 2024 | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta N... | Due to potential system error alarm and the inability to initiate therapy as a result of broken o... | Class II | KCI USA, INC. |
| Nov 1, 2024 | Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Nov 1, 2024 | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM... | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the ext... | Class I | Medtronic Neurosurgery |
| Oct 15, 2024 | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340... | Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes... | Class III | Alcon Research LLC |
| Aug 22, 2024 | Healgen Series Reagent strips for Urinalysis are composed of several color pa... | The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent S... | Class II | Healgen Scientific Llc |
| Aug 8, 2024 | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, ... | Material with a quality issue was used in contact lens production, so contact lenses may not meet... | 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 SATINSLIT FULL HANDLE2.75MM AN 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: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 806583007... | 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 INTREPID DB,2.2 Model/Catalog Nu... | 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 INTREPID DB,2.4 Model/Catalog Nu... | 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 INTREPID SB,2.2 Model/Catalog Nu... | 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 INTREPID SB,2.4 Model/Catalog Nu... | 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 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 ... | 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 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 |
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.