Browse Device Recalls
2,945 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,945 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 2,945 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO I... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Aug 30, 2024 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... | Class I | Fresenius Kabi USA, LLC |
| Aug 23, 2024 | Non-ablative Fractional Laser Systems, Model: WFB-01 | Model WFB-01 sold to US customers before Aug 23, 2022 has been found to have a software bug (6 un... | Class II | WINGDERM ELECTRO-OPTICS LTD. |
| Aug 22, 2024 | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The Stea... | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navig... | Class II | Medtronic Navigation, Inc. |
| Aug 19, 2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Versio... | Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when use... | Class II | Hologic Inc |
| Aug 15, 2024 | ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 15, 2024 | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 1133579... | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per sec... | Class II | Siemens Medical Solutions USA, Inc. |
| Aug 12, 2024 | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FA... | Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube a... | Class II | Becton, Dickinson and Company, BD Bio Sciences |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... | Class I | Datascope Corp. |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.01) for outside the US to mitigate product p... | Class I | Datascope Corp. |
| Aug 8, 2024 | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... | Class I | Datascope Corp. |
| Aug 8, 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system ... | Firm has developed a software correction (Revision D.00) outside the US to mitigate product probl... | Class I | Datascope Corp. |
| Aug 7, 2024 | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/o... | Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the... | Class II | Fisher & Paykel Healthcare, Ltd. |
| Aug 2, 2024 | Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Cata... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Aug 2, 2024 | Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Mode... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Aug 2, 2024 | Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Re... | Due to a manufacturing issue, red particulates present in the expressed composite. | Class II | Ultradent Products, Inc. |
| Jul 19, 2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System... | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specific... | Class II | Biointellisense Inc. |
| Jul 17, 2024 | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | Software anomalies which can result in two separate issues: A lagging screen display during a nav... | Class II | Mazor Robotics Ltd |
| Jul 17, 2024 | Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 17, 2024 | Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with eith... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 16, 2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 806583007... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Nu... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Nu... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Nu... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Nu... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
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.