Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2025 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 | 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 MP60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 | 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-Q170 | 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, 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 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 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 | 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 | 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 |
| 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 |
| 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 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 | 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 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 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 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 | 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 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 | 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 | 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 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 | 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 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. 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 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 | Model Number L211 PROPONENT 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 | 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 | 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 | 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 L221 PROPONENT 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 | Model Number S702, ALTRUA 2 DR 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 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 L121 ESSENTIO 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 SR SL (Model L200) | 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 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 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 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 | 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 L209 PROPONENT DR (VDD) 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 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 L101, ESSENTIO DR 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 L231, PROPONENT DR EL MRI Pacemaker | 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.