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.

Clear
DateProductReasonClassFirm
Jul 2, 2025 Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-32... Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error messa... Class II Spark Biomedical Inc
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model PURE 5000/10000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 30, 2025 Laser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000. The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box... Class II Beyond Laser Systems, LLC
Jun 25, 2025 DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combinati... Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Pot... Class II Nuclein LLC
Jun 24, 2025 PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-37... A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect... Class II Orthofix U.S. LLC
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... Class II Encore Medical, LP
Jun 12, 2025 Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobi... Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued di... Class II Encore Medical, LP
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
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

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.