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
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 17, 2017 ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... Class I OriGen Biomedical, Inc.
Jan 11, 2017 Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quanti... Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read ... Class II Ortho Kinematics, Inc
Jan 10, 2017 Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert a... The Empowr PS Insert was reported as missing the impaction slot feature. Class II Encore Medical, Lp
Jan 10, 2017 LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Mo... Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal ... Class II Encore Medical, Lp
Dec 13, 2016 Chord-X Chordal Sizer is designed to assist in determining the proper length ... Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Lef... Class II On-X Life Technologies, Inc.
Dec 8, 2016 Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O ... Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a pri... Class II Trilliant Surgical Ltd.
Nov 15, 2016 Empowr Knee System Product Usage: Non-porous proximal tibial baseplate im... A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, ma... Class II Encore Medical, Lp
Nov 7, 2016 Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I... Due to a customer experiencing complaints on bone fraction of assay not being in range. The co... Class III Helena Laboratories, Inc.
Oct 14, 2016 Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL Due to customer-experienced complaints on narrow assay range compared to prior lots and the user ... Class II Helena Laboratories, Inc.
Oct 4, 2016 Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ... Potential contamination with B. cepacia. Class I Nurse Assist, Inc
Sep 19, 2016 Empowr PS Knee System Box Cut Guide; Used to make the housing resection for ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Sep 19, 2016 Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to ... It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone rem... Class II Encore Medical, Lp
Sep 8, 2016 MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. ... The supplier initiated a recall because affected lots of the micro-introducer have an outer diame... Class II Argon Medical Devices, Inc
Sep 7, 2016 Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily im... The device has the potential to be packaged in the wrong product box. Class II Osteogenics Biomedical, Inc.
Sep 5, 2016 Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySo... The intraocular lens could become lodged within the cartridge Class II Alcon Research, Ltd.
Sep 2, 2016 Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 ... Screws were identified as having the incorrect part number and lot number marked upon them. The ... Class II Trilliant Surgical Ltd.
Aug 29, 2016 ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model... The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of ... Class II LDR Spine USA, Inc.
Aug 12, 2016 Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. ... Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug... Class II Ortho Kinematics, Inc
Aug 9, 2016 Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 a... Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class II Mentor Texas, LP.
Aug 9, 2016 CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can b... The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. Class II Mentor Texas, LP.
Jul 28, 2016 Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Al... The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that coul... Class II Alcon Research, Ltd.
Jul 28, 2016 LAUREATE World Phaco System Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) Class II Alcon Research, Ltd.
Jul 26, 2016 Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two s... The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone c... Class II Encore Medical, Lp
Jul 1, 2016 Mentor MemoryGel Breast Implant; Indicated for females for breast augmentatio... The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. Class II Mentor Texas, LP.
Jun 21, 2016 MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 a... Reported failure of the instrument. The retaining ring component of a neck trial became disassem... Class II Encore Medical, Lp
May 24, 2016 CENTURION Vision System The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment ... Class II Alcon Research, Ltd.
May 13, 2016 Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number:... Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a pot... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Apr 28, 2016 CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision Syst... Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS ... Class II Alcon Research, Ltd.
Apr 27, 2016 Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set scr... There is a possibility that the subject set screw driver could disengage from the torque limiting... Class II Orthofix, Inc
Apr 20, 2016 Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... Due to some cards in this lot experiencing variations in wave form, resulting in some cards with ... Class II Helena Laboratories, Inc.
Apr 14, 2016 LenSx Laser System. Indicated for use in patients undergoing cataract surger... Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after rec... Class II Alcon Research, Ltd.
Apr 8, 2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for u... Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecti... Class II Medtronic Sofamor Danek Usa, Inc - Dallas Distr...
Mar 3, 2016 TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ... During functional testing of devices after real time aging, it was determined that product failed... Class II ArthroCare Corporation
Mar 1, 2016 VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Gu... Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision P... Class II Alcon Research, Ltd.
Feb 17, 2016 ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and... The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheat... Class II Argon Medical Devices, Inc
Jan 8, 2016 Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intend... There is a possibility that the device may deliver a torque value less than the required setting ... Class II Orthofix, Inc
Jan 5, 2016 InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, S... Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class II Rymed Technologies, LLC
Jan 5, 2016 InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposabl... Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class II Rymed Technologies, LLC
Dec 18, 2015 VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjuncti... Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring ... Class II Cyberonics, Inc
Dec 8, 2015 AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 C... The trial shell mating feature on the broach is undersized. Class II Encore Medical, Lp
Nov 25, 2015 ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the ap... There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C... Class II KCI USA, INC.
Nov 24, 2015 Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use wit... The sterile blade will not fit into the handle provided with the ETTD system. Class II Instratek, Incorporated
Nov 18, 2015 Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartb... Class II Cyberonics, Inc
Nov 5, 2015 Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior C... Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft... Class II Genesys Orthopedics Systems, 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.