Browse Device Recalls
774 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 774 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 774 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use i... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a ... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 20, 2024 | Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a phar... | Baxter Healthcare Corporation has received increased customer reports of particulate matter in th... | Class I | Baxter Healthcare Corporation |
| Aug 19, 2024 | IntelliSystem Inflation Device, REF: IN1525/D | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | StabiliT TOUCH Syringe, REF: IN8VCF/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8140/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | BlueFIRE Inflation Device, REF: IN10140 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixSKY Inflation Device, REF: SKY1802 | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K0... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Aug 19, 2024 | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, I... | Inflation devices may have a small hole in the sterile barrier of the device and use of affected ... | Class II | Merit Medical Systems, Inc. |
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, Inc. |
| Jun 24, 2024 | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 56... | Any single affected ventilator should only be used for the 10- year labelled service life, but if... | Class I | Covidien |
| May 13, 2024 | Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh... | The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg... | Class II | Roche Diabetes Care, Inc. |
| May 3, 2024 | SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical ... | 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 XR and 3.0T- Magnetic Resonance (MR) systems are Med... | 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 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 |
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.