Browse Device Recalls
806 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 806 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 806 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2024 | SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical El... | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| May 3, 2024 | SmartPath to dStream for 3.0T Model Number (REF): 782145 | The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hot... | Class II | Philips North America Llc |
| Apr 29, 2024 | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 4, 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0... | Unreleased software was installed on customer systems resulting in the visual feedback on the scr... | Class II | Stryker Leibinger GmbH & Co. KG |
| 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 12, 2024 | SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | SmartPath to dStream for 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Mar 1, 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Potential for a leak path at the seal interface between the left ventricle assist system inflow c... | Class I | Thoratec Corp. |
| Jan 8, 2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... | Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... | Class II | Maquet Medical Systems USA |
| Jan 8, 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... | Class II | Microbiologics Inc |
| Jan 3, 2024 | SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Dec 29, 2023 | SmartPath to dStream for 1.5T, Model No. 781260, 782112 | An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (L... | Class III | Philips North America |
| Dec 11, 2023 | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON... | There is the potential for incomplete staple line formation during the firing sequence, without m... | Class II | Ethicon Endo-Surgery Inc |
| Oct 23, 2023 | SmartPath to dStream for 1.5T | Potential component failure in the Gradient Coil could product smoke and/or fire. | Class II | Philips North America Llc |
| Oct 11, 2023 | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal l... | May have increased water path restriction within the heat exchanger, leading to degraded heat exc... | Class II | Mc3 Inc |
| Oct 11, 2023 | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal lif... | May have increased water path restriction within the heat exchanger, leading to degraded heat exc... | Class II | Mc3 Inc |
| Sep 26, 2023 | AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH10... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | SENTIERO, mobile medical devices for hearing examinations, Model Number SOH10... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | SENTIERO Screening2, mobile medical devices for hearing examinations, Model N... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Sep 26, 2023 | SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Nu... | Affected lots of product may experience technical distortions to a greater extent than expected. | Class II | PATH |
| Aug 25, 2023 | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 25, 2023 | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Aug 25, 2023 | Multichem P, Part Code 08P90-10 | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill ... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after ... | Class II | Philips North America |
| Jun 12, 2023 | Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782... | During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector... | Class II | Philips North America |
| Jun 6, 2023 | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing... | If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the who... | Class II | Hamamatsu Corporation |
| Jun 5, 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| Jun 5, 2023 | VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 | It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... | Class II | Luminex Corporation |
| May 15, 2023 | Philips Respironics V60 Ventilator-Intended to mechanically control or assist... | Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may po... | Class II | DRE Medical Group Inc |
| Mar 10, 2023 | Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 175... | Sterility; Steril surgical procedure packs contain incomplete seals. | Class II | Alcon Research, LLC |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Sin... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed ... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two U... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designe... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Singl... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Feb 1, 2023 | BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed f... | Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of lo... | Class II | Becton Dickinson & Company |
| Nov 22, 2022 | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT- Intended for IV access device ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Sep 19, 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie... | Class II | DeVilbiss Healthcare LLC |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... | Class II | Johnson & Johnson Surgical Vision, Inc. |
| Jun 17, 2022 | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP... | Class II | Luminex Corporation |
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.