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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 2, 2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KN... | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use ... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Mar 27, 2025 | GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intende... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Needle REF NDL-107-04 These needles are used for the percutane... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 27, 2025 | B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 61280... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-0... | Due to a potential open seal in the sterile barrier packaging . | Class II | Galt Medical Corporation |
| Mar 27, 2025 | GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutan... | Due to a potential open seal in the sterile barrier packaging. | Class II | Galt Medical Corporation |
| Mar 21, 2025 | Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may incre... | Class II | Phasor Health, LLC |
| Feb 20, 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... | Class II | Orthofix U.S. LLC |
| Feb 10, 2025 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12... | Customer-designed sterile surgical procedure packs contain latex components as specified; but, th... | Class II | Alcon Research LLC |
| Jan 17, 2025 | 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plu... | Due to increase in complaints related to leak alarms | Class II | KCI USA, INC. |
| Jan 17, 2025 | 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US -... | Due to increase in complaints related to leak alarms | Class II | KCI USA, INC. |
| Jan 3, 2025 | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| Jan 3, 2025 | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/... | Their is a potential that implanted pulse generators may stop delivering therapy due to an intern... | Class II | LivaNova USA, Inc. |
| 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 |
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.