Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 15, 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang... | Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas. | Class II | Alcon Research, LLC |
| Mar 15, 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... | Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... | Class II | SPINEART SA |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 14, 2024 | Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, ... | Surgical convenience kits containing Pure Pouch component that has weak seals which may result in... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 11, 2024 | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Mar 11, 2024 | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would... | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump... | Class II | Smith & Nephew Medical, Ltd. |
| Feb 29, 2024 | Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometri... | The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) ass... | Class II | Beckman Coulter, Inc. |
| Feb 26, 2024 | Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18... | Complaints have been received that the device inflation tube detached and/or tore from the main t... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2024 | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 19, 2024 | HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... | Class I | Thoratec Corp. |
| Feb 14, 2024 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30... | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Feb 14, 2024 | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner poten... | Class II | Covidien, LP |
| Jan 30, 2024 | Epix Universal Clip Applier, REF: CA500, STERILEEO included within the follow... | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. | Class II | Applied Medical Resources Corp |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, Interlink Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 22, 2024 | Medtronic Duet External Drainage and Monitoring System, SmartSite Injection S... | Potential for catheter disconnection from the patient line stopcock connectors. | Class I | Medtronic Neurosurgery |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 15, 2024 | Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) | When using those products you may experience difficulties to extend or retract the laser fiber, a... | Class II | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. |
| Jan 3, 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... | Due to software and controller systems that results in unexpected pump start or pump stop. | Class I | Thoratec Corp. |
| Dec 15, 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model... | Devices may not be rendered sterile due to an internal gap that may be present on some devices ca... | Class II | Globus Medical, Inc. |
| Dec 12, 2023 | Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 | Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... | Class II | Steris Corporation |
| Dec 12, 2023 | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | Dual-articulating head rest may not stay in place or may fail to lock into position during a pati... | Class II | Steris Corporation |
| Dec 1, 2023 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... | Class II | Maquet Cardiovascular, LLC |
| Dec 1, 2023 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. T... | Class II | Maquet Cardiovascular, LLC |
| Nov 28, 2023 | Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... | Class II | AtriCure, Inc. |
| Nov 28, 2023 | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... | Class II | AtriCure, Inc. |
| Nov 15, 2023 | Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TR... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, RE... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Nov 15, 2023 | MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, ... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific ... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 31, 2023 | 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Mod... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numbe... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number ... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OU... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 31, 2023 | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Numb... | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. T... | Class II | Heartware, Inc. |
| Oct 4, 2023 | Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Oct 4, 2023 | FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Oct 4, 2023 | TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 ... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Oct 4, 2023 | FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Oct 4, 2023 | TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Oct 4, 2023 | Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx on... | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with... | Class II | Edwards Lifesciences, LLC |
| Sep 27, 2023 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 27, 2023 | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support ... | A software library filtering error has been discovered which occurs when users are using the Step... | Class II | Exocad GmbH |
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.