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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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. |
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.