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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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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 30, 2014 PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Dec 9, 2013 Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 20... A sharp edge on the cannulated tip of the device may damage or cut a suture. Class II ArthroCare Medical Corporation
Nov 26, 2013 Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver... Orthofix received 6 complaints which resulted in a reportable events due to extended surgical tim... Class II Orthofix, Inc.
Nov 20, 2013 All brochures printed before November 20, 2013 for the HyperBlue 1530 medical... Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had... Class II Hyperion Medical
Oct 29, 2013 Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Tit... There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fractu... Class II Orthofix, Inc
Oct 18, 2013 CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" Product has the potential to have a clear debris on the tip of the needle. Class II Intra Pump Infusion Systems
Sep 13, 2013 Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparosc... CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed... Class II CooperSurgical, Inc. D.B.A. Lone Star Medical P...
Sep 11, 2013 The Rotoprone therapy System is an advanced patient care system for the treat... The lock pin can become stuck in the "in" position during the manual rotation, resulting in the i... Class II ArjoHuntleigh Inc.
Aug 12, 2013 Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for th... Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration ... Class II Abbott Laboratories, Inc
Jul 31, 2013 VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint config... The product has the potential to be laser marked as a Medium when it actually is a Small. Class II Spine Smith Holdings, LLC
Jul 25, 2013 Stryker Visum 300 Ceiling-mounted Exam Light. Potential incomplete final weld on the drop tube flange. Class II Stryker Communications
May 24, 2013 VIA Medical Collection Bag; The collection bag is an accessory waste bag use... International Biomedical has received reports of interference between the collection bag and the ... Class II International Biomedical, Ltd.
Apr 25, 2013 Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 ... Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. Class II Instratek, Incorporated
Apr 1, 2013 3DKnee e+ Tibial Insert. The insert is used along with the other components t... U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels... Class II Encore Medical, Lp
Mar 4, 2013 Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product... An internal review of CareFusion's labeling for preoperative skin prep product codes was recently... Class III CareFusion 213, LLC
Feb 20, 2013 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterio... Manufacturing residue may be present on the cervical screws. Use of this product may result in p... Class II Genesys Orthopedic Systems, LLC
Feb 1, 2013 Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial R... There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connect... Class II Orthofix, Inc
Dec 20, 2012 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoP... The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has t... Class II Healthtronics, Inc.
Dec 18, 2012 ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Quali... Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative ... Class II Abbott Laboratories, Inc
Dec 5, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... B. Braun Medical Inc. is informing our customers of a field correction previously performed to ad... Class II B Braun Medical, Inc.
Nov 30, 2012 Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 371... There is issues of warmth or heating at the implant site during charging for the Eon Mini implant... Class II St. Jude Medical
Nov 16, 2012 Clinical Chemistry Phenobarbital, list number 1E08 Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773... Class II Abbott Laboratories, Inc
Nov 14, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class I B Braun Medical, Inc.
Oct 31, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class II B Braun Medical, Inc.
Oct 24, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. Th... Class II B Braun Medical, Inc.
Sep 28, 2012 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the ac... A product complaint was received where a size 20 screw was labeled as size 30. After receipt, mea... Class II Encore Medical, Lp
Sep 25, 2012 (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker F... Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Ar... Class II Stryker Communications, Inc.
Sep 18, 2012 Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blad... Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which c... Class II Instratek, Incorporated
Sep 17, 2012 BariAir Therapy System The BariAir Therapy System is a risk management tre... KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The Bari... Class II KCI USA, Inc.
Sep 4, 2012 The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,... Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimu... Class II Advanced Neuromodulation Systems Inc.
Aug 24, 2012 Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft,... Implants were incorrectly laser marked as 23mm instead of 28mm. Class II Spine Smith Partners LP
Aug 9, 2012 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vi... The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The s... Class II Encore Medical, Lp
Aug 6, 2012 Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distra... There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during... Class II Orthofix, Inc
Jul 26, 2012 Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated ... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: E... St. Jude Medical has informed your doctor that a number of cases have been reported in which disc... Class II St. Jude Medical
Jul 26, 2012 Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana... As part of St. Jude Medical's routine tracking and product monitoring, they have received a total... Class II St. Jude Medical
Jul 16, 2012 djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for t... One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint ... Class II Encore Medical, Lp
Jun 27, 2012 RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and preventio... The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy Syste... Class II KCI USA, Inc.
Jun 11, 2012 Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... This letter is to notify you that several of our sterile screw products are being voluntarily rec... Class II Tedan Surgical Innovations Llc
May 29, 2012 This voluntary medical device correction is related to Alcon products that pr... This medical device correction is related to Alcon products that present a 23G non-valved trocar ... Class II Alcon Research, LTD.
May 29, 2012 IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Tran... There was an error on the outer labeling of this device. The inner label was correct. Class II IDEV Technologies, Inc.
May 4, 2012 Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek ba... Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may comprom... Class II Argon Medical Devices, Inc
Mar 28, 2012 Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator... Unintended Fluid ingress into the device header has been shown. Class II Advanced Neuromodulation Systems Inc.
Dec 19, 2011 Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be con... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th... Class II Advanced Neuromodulation Systems Inc.
Dec 19, 2011 The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rech... As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at th... Class II Advanced Neuromodulation Systems Inc.
Dec 19, 2011 Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indica... The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or... Class II Advanced Neuromodulation Systems 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.