Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2025 | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... | The product in incorrectly labeled. The label indicates that the skive hole should be above the b... | Class II | Boston Scientific Corporation |
| 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 | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4... | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c... | Class II | Howmedica Osteonics Corp. |
| 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 27, 2025 | The AlignRT InBore system contains six Class 1 lasers which enables the syste... | Vision RT is informing customers of an omission identified in the Instructions for Use for AlignR... | Class II | Vision RT Ltd |
| Aug 26, 2025 | GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH0500... | Reports of vascular graft delamination, which may lead to reduced access flow; cannulation diffic... | Class II | W L Gore & Associates, Inc. |
| Aug 26, 2025 | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 26, 2025 | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the curre... | Class II | OSSTEM Implant Co., Ltd. |
| Aug 25, 2025 | Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636... | Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a... | Class II | LeMaitre Vascular, Inc. |
| Aug 22, 2025 | Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breath... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 22, 2025 | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 ... | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dro... | Class II | Sonesta Medical AB |
| Aug 22, 2025 | MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multic... | If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can re... | Class II | GE Medical Systems, LLC |
| Aug 22, 2025 | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 22, 2025 | MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. ... | One lot manufactured with an invalid sterilization cycle. | Class II | CooperVision, Inc. |
| Aug 21, 2025 | i-STAT EG7+ cartridge. List Number: 03P76-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden... | Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification featu... | Class II | Bard Peripheral Vascular Inc |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , R... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K... | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, 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 21, 2025 | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type... | Class II | Abbott Point Of Care Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx ... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | i-STAT EG6+ cartridge. List Number: 03P77-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| 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 |
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.