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 |
|---|---|---|---|---|
| Jun 3, 2014 | eye-pak 7407 Tray Support Cover REF 8065740745 | The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot... | Class II | Alcon Research, Ltd. |
| May 19, 2014 | CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 | Blade can shift during shipping which makes the product ineffective. | Class II | KCI USA, Inc. |
| May 16, 2014 | Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Numbe... | Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actua... | Class II | Alcon Research, Ltd. |
| Apr 7, 2014 | Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite... | Package inserts have incorrect SmartWash parameters for Triglyceride. | Class II | Abbott Laboratories, Inc |
| Apr 2, 2014 | Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of ... | The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Ge... | Class II | Genesys Orthopedics Systems, LLC |
| Mar 31, 2014 | EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 | The voluntary recall is due to the needle set not meeting its specifications. | Class II | Vidacare Corporation |
| Mar 17, 2014 | SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the servi... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the s... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the ser... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 17, 2014 | SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attach... | During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S... | Class II | Stryker Communications |
| Mar 8, 2014 | Neusoft NeuViz 64 Multi-slice CT Scanner System | The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing... | Class II | Neusoft Medical System Co |
| Feb 7, 2014 | FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... | Packaging error -- two different types and sizes of acetabular liners used during hip replacement... | Class II | Djo Surgical |
| Jan 30, 2014 | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2001: Prevena Incision Management Customizable System Box Product Usage... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| Jan 30, 2014 | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... | Class II | KCI USA, INC. |
| 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. |
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.