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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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.

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DateProductReasonClassFirm
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.
Jul 20, 2015 Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea... Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t... Class II Trilliant Surgical Ltd.
Jul 20, 2015 Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, ... The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to... Class II Trilliant Surgical Ltd.
Jun 24, 2015 FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01... The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anteri... Class II Encore Medical, Lp
Jun 18, 2015 Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 18, 2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... Potential defect in the forming of the primary package of the blister that may compromise the ste... Class II Argon Medical Devices, Inc
Jun 12, 2015 OxySure Model 615 disposable replacement cartridges, for portable oxygen gene... Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimu... Class II Oxysure Systems, Inc.
Jun 9, 2015 Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Gui... Inadequate interference between the screw and the plate when screw implanted into the plate at an... Class II Alliance Partners LLC
Jun 2, 2015 Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalo... Insufficient seal on the outside packaging, potentially affecting the sterility of the product. Class II Alcon Research, Ltd.
Jun 2, 2015 EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable ... Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (H... Class II ArthroCare Corporation
May 18, 2015 ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Sta... The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabel... Class II Orthofix, Inc
May 15, 2015 PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLAS... Potential component failure resulting in inoperability Class II ArthroCare Medical Corporation
May 15, 2015 EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA ... Potential component failure causing device inoperability Class II ArthroCare Medical Corporation
May 12, 2015 T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm ... Potential breach in sterility Class II Vidacare Corporation
May 11, 2015 ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill G... There is a possibility that the thumb button remains in the depressed (unlocked) position allowin... Class II Orthofix, Inc
Apr 28, 2015 The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use... The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves d... Class II Alcon Research, Ltd.
Apr 21, 2015 PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT... At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was... Class II Hitachi America, Ltd., Power Systems Division
Apr 15, 2015 ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcryS... There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) ... Class I Alcon Research, Ltd.
Mar 30, 2015 OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO... Potential for clear extension tube to separate from the hub, which could result in blood loss and... Class I OriGen Biomedical, Inc.
Mar 30, 2015 REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO... Potential for clear extension tube to separate from the hub, which could result in blood loss and... Class I OriGen Biomedical, Inc.

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.