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 |
|---|---|---|---|---|
| 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 |
| Oct 28, 2015 | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat e... | The products have been found to intermittently exhibit a seal failure during use. | Class II | Quest Medical, Inc. |
| Oct 26, 2015 | Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation ... | There is cracking in the tray when the device is snapped into place. The crack is through the ful... | Class II | ArthroCare Corporation |
| Oct 21, 2015 | Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used... | The wire pass hole is not present on the tools. | Class II | Medtronic Sofamor Danek Usa, Inc - Dallas Distr... |
| Oct 7, 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 |
| Sep 29, 2015 | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric... | Continued increase in reports of post-operative inflammation in patients who received AcrySof IQ ... | Class I | Alcon Research, Ltd. |
| Sep 21, 2015 | Custom Pak 9319-27. Single-use medical devices and accessories designed by m... | The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than th... | Class II | Alcon Research, Ltd. |
| Sep 16, 2015 | Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For us... | The labeling is missing the size/diameter information. | Class II | Encore Medical, Lp |
| Sep 15, 2015 | AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba... | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ... | Class II | Encore Medical, Lp |
| Sep 14, 2015 | Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon ... | During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Imp... | Class II | Encore Medical, Lp |
| Sep 14, 2015 | Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction ... | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form t... | Class II | Encore Medical, Lp |
| Sep 9, 2015 | ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vit... | Incorrect tubing. | Class II | Abbott Laboratories, Inc |
| Aug 11, 2015 | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue... | Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports... | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | Alcon 23G and 25G Valved Entry System provides access into the posterior segm... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | Custom Paks containing 23G and 25G valved trocar cannula provide access into ... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
| Aug 11, 2015 | 23G and 25G Constellation Totalplus Paks provides access into the posterior s... | The product has potential to leak beyond their design specification. | Class II | Alcon Research, Ltd. |
| Aug 7, 2015 | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL... | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... | Class II | International Biophysics Corp. |
| Aug 7, 2015 | IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wan... | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... | Class II | International Biophysics Corp. |
| Aug 7, 2015 | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH... | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance... | Class II | International Biophysics Corp. |
| Aug 6, 2015 | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONL... | The affected parts subject to the recall are out of specification, resulting in in the loss of th... | Class II | Trilliant Surgical Ltd. |
| Jul 31, 2015 | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot ... | Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specifica... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw Syste... | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the g... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.... | The cutting efficiency of the Countersinks was out of specification. | Class II | Trilliant Surgical Ltd. |
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.