Browse Device Recalls

3,415 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,415 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 3,415 FDA device recalls — Class I.

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DateProductReasonClassFirm
Sep 11, 2025 EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 11, 2025 BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ... Infusion pump module used with compatible pump infusion sets may perform outside the establishe... Class I CareFusion 303, Inc.
Sep 11, 2025 EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... Class I Olympus Corporation of the Americas
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), ... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), RE... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), RE... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), ... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 10, 2025 TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), ... Abbott has become aware of a limited number of tip detachment events during catheter removal from... Class I Abbott
Sep 9, 2025 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I The unexpected internal fault / system diagnostic error to result when a rapid succession of butt... Class I NOXBOX LTD
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I Fluctuations may be more likely to occur if the total flow through the device sensor (used by the... Class I NOXBOX LTD
Aug 28, 2025 MAGNETOM Verio Dot. Model Number: 10684333. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 BIOGRAPH One (DE). Model Number: 11689172. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Prisma. Model Number: 10849582. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Connectom.X. Model Number: 11371480. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio Dot Upgrade. Model Number: 10684334. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dex... A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpec... Class I Dexcom, Inc.
Aug 28, 2025 MAGNETOM Cima.X (DE). Model Number: 11647158. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra fit. Model Number: 10849580. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida Fit. Model Number: 11410481. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Lumina (DE). Model Number: 11344916. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Verio. Model Number: 10276755. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 Biograph mMR. Model Number: 10433372. There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 28, 2025 MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111... There is a potential for an ice blockage to form or currently exist within the magnet venting sys... Class I Siemens Medical Solutions USA, Inc
Aug 21, 2025 Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-... The kits contain certain lots of cannula products where the catheter may not retain its shape. Class I Medline Industries, LP
Aug 20, 2025 ACCOLADE DR SL MRI (Model L311) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S722, ALTRUA 2 DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT DR SL (Model L201) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL MRI (Model L310) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L100, ESSENTIO SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U125, VALITUDE CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL (Model L300) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L111, ESSENTIO DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S701 ALTRUA 2 SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL (Model L321) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR SL (Model L301) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L210 PROPONENT SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U225 VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L110, ESSENTIO SR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL MRI (Model L331) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L131, ESSENTIO DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U228, VISIONIST CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific 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.