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.

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DateProductReasonClassFirm
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.