Browse Device Recalls
249 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 249 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 249 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, ... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, P... | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Mar 8, 2019 | Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T | The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFI... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Mar 6, 2018 | Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintai... | Incorrect gel part number listed in a master manufacturing record | Class II | Integra LifeSciences Corp. |
| Dec 20, 2017 | The humeral stems trials are packaged in a kit for Titan Modular Shoulder Sys... | Incidents of stem trial breakage were reported to the firm suggesting that these fractures all oc... | Class II | Integra LifeSciences Corp. |
| Sep 26, 2017 | Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; C... | A faulty footswitch may result in unintended ultrasonic fragmentation activation. There are two ... | Class II | Integra LifeSciences Corp. |
| Aug 18, 2017 | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 | A quarantined lot of the devices was released for sale. Devices from this lot may experience incr... | Class II | Integra LifeSciences Corp. |
| Mar 3, 2017 | Panta Nail, Rx only, Sterile, | Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the ... | Class II | Integra LifeSciences Corp. |
| Jan 25, 2017 | The UNI-CP System; Model Number: 330230SND. | The firm received one complaint from one non-US sales representative (France) that the label on t... | Class III | Integra LifeSciences Corp. |
| Jan 20, 2017 | Integra Cadence Total Ankle System | Posterior tibial fractures have been reported. | Class II | Integra LifeSciences Corp. |
| Aug 24, 2016 | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND | Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC invol... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 24, 2016 | PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide... | Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalog... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Aug 23, 2016 | Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx on... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, package... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, ... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 23, 2016 | Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packag... | During final sampling inspection, one of the lots was discovered with a total incomplete packagin... | Class II | Integra LifeSciences Corp. |
| Aug 4, 2016 | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Jul 21, 2016 | Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, ... | Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "position... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | Integra External Fixation System Slotted Post - Small Catalogue #12224228; In... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 20, 2016 | Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catal... | Through the investigation of reported complaints Integra verified that there have been instances ... | Class II | Integra LifeSciences Corp. |
| Jul 1, 2016 | Integra External Fixation System Rocker Bottom Model # 12225400. For use i... | The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose ... | Class II | Integra LifeSciences Corp. |
| Jun 17, 2016 | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The... | Data from internal studies suggests there may be a potential that the secondary package seal inte... | Class II | Integra LifeSciences Corp. |
| May 20, 2016 | K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture... | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made o... | Class II | Integra LifeSciences Corp. |
| May 10, 2016 | TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Scre... | As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Ga... | Class II | Integra LifeSciences Corp. |
| Apr 29, 2016 | Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis th... | As a result of an internal review of all labeling for the Cadence System, it was determined that ... | Class II | Integra LifeSciences Corp. |
| Mar 7, 2016 | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Reports relating to unintended patient or operator burns or operator electric shock for some of I... | Class II | Integra LifeSciences Corp. |
| Mar 7, 2016 | Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments | Reports relating to unintended patient or operator burns or operator electric shock for some of I... | Class II | Integra LifeSciences Corp. |
| Sep 22, 2015 | Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... | Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
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.