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 |
|---|---|---|---|---|
| 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. |
| Mar 16, 2015 | Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 ... | Battery packs may heat up abnormally and ignite in rare instance. | Class II | Arcos, Inc |
| Mar 6, 2015 | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Gener... | The pulse generators have a lower battery longevity than specified in their design requirement as... | Class II | Cyberonics, Inc |
| Feb 26, 2015 | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthal... | Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels | Class II | Quest Medical, Inc. |
| Feb 23, 2015 | Mobius3D Product Usage: Mobius3D software is used for quality assurance a... | Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam c... | Class II | Mobius Medical Systems, LP |
| Feb 20, 2015 | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E)... | The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L... | Class II | ArthroCare Medical Corporation |
| Feb 3, 2015 | Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made ... | The toothbrush head can potentially disengage from the handle. | Class II | Norwex Usa Inc |
| Jan 15, 2015 | ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the ... | There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to th... | Class II | Abbott Laboratories, Inc |
| Jan 13, 2015 | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 70... | The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. | Class II | Med-logics Inc |
| Dec 11, 2014 | MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Bre... | The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect.... | Class II | Mentor Texas, LP. |
| Nov 20, 2014 | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Ther... | The recalled product was distributed with an incorrect serial number printed on the device's label. | Class II | Cyberonics, Inc |
| Nov 19, 2014 | CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only M... | KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component o... | Class II | KCI USA, INC. |
| Nov 11, 2014 | Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ... | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to ... | Class II | Alcon Research, Ltd. |
| Oct 30, 2014 | INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. S... | Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in t... | Class II | Alcon Research, Ltd. |
| Oct 27, 2014 | Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switc... | Potential breach of sterile barrier due to defective product tray. | Class II | ArthroCare Medical Corporation |
| Oct 6, 2014 | Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters ... | Patients have experienced a bad taste associated with the filters. | Class II | Alliance Tech Medical, Inc |
| Oct 6, 2014 | INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718... | The recalling firm received complaints related to leakage from the tubing near the white luer of ... | Class II | Alcon Research, Ltd. |
| Sep 29, 2014 | ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic ... | Product is mislabeled. | Class II | 4-Web Inc. |
| Sep 24, 2014 | Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed... | The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay eng... | Class II | Joerns Healthcare |
| Sep 18, 2014 | Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 ... | The single leg of the PAY connector has been observed to become detached. | Class II | Dokitz NovoSci |
| Sep 18, 2014 | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration an... | A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufa... | Class II | KCI USA, Inc. |
| Sep 12, 2014 | Prescription eyeglass safety lenses. Vision correction | Prescription eyeglass safety lenses did not meet specifications. | Class II | Eyemart Express Ltd |
| Aug 15, 2014 | LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Ac... | Product was distributed past its expiration date. | Class II | Apollo Endosurgery Inc |
| Jul 29, 2014 | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as p... | The Directions for Use (DFU) manual contains information for devices that are not approved in the... | Class II | St. Jude Medical, Inc. |
| Jul 29, 2014 | Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as p... | The Directions for Use (DFU) manual contains information for devices that are not approved in the... | Class II | St. Jude Medical, Inc. |
| Jul 25, 2014 | Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (... | Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca... | Class II | Estill Medical Technologies, Inc |
| Jul 25, 2014 | GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-S... | The adhesive used in the product could dislodge when objects are inserted through the valve which... | Class II | Galt Medical Corporation |
| Jul 25, 2014 | GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO ... | The adhesive used in the product could dislodge when objects are inserted through the valve which... | Class II | Galt Medical Corporation |
| Jul 2, 2014 | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us... | The device labeling is stamped with 330cc and the device is actually 380cc device. | Class II | Mentor Texas, LP. |
| Jun 5, 2014 | UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 320... | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... | Class II | Argon Medical Devices, Inc |
| Jun 5, 2014 | UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 3... | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... | Class II | Argon Medical Devices, Inc |
| Jun 5, 2014 | UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524... | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at... | Class II | Argon Medical Devices, 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.