Browse Device Recalls
835 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 835 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 835 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 28, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R1... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S),... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software V... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 a... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 78... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. ... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 28, 2026 | MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; So... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM ... | Class II | Philips North America |
| Aug 28, 2026 | Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3... | When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM... | Class II | Philips North America |
| Aug 21, 2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dS... | A software issue will terminate an examination during the image reconstruction process if the sca... | Class II | Philips North America Llc |
| Aug 14, 2026 | Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog N... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 12, 2026 | Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia ... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 12, 2026 | Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumo... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 12, 2026 | Generic Name: BioFire¿ Joint Infection (JI) Panel Generic Name: BioFire¿ Join... | Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could ... | Class II | BioFire Diagnostics, LLC |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected the accuracy of the... | Class II | Baxter Healthcare Corporation |
| Jul 22, 2026 | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Powe... | A subset of power adapters used with the connect console may exhibit higher-than-expected resista... | Class II | Boston Scientific Corporation |
| Jul 8, 2026 | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experien... | Class II | Fort Defiance Industries, LLC |
| Jun 30, 2026 | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas St... | Due to incorrect machining of peripheral screw hole resulting in potential for improper engagemen... | Class II | restor3d Inc. |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 cou... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Produc... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Prod... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 30, 2026 | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, ... | Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration... | Class II | Medline Industries, LP |
| Jun 26, 2026 | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000 | A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short... | Class II | Erbe USA Inc |
| Jun 19, 2026 | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control ... | A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When th... | Class II | MUNEVO GMBH |
| May 13, 2026 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| May 13, 2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to 11 volt Backup Battery failures. | Class II | Thoratec LLC |
| May 12, 2026 | IV Sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | IV Sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | IV Non-Dedicated Gravity Administration Sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | IV Sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | Plum administration sets | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | IV Sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | Oncology sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 12, 2026 | Oncology sets with drip chambers | Intravascular administration tubing set drip chambers may have black specks potentially due to th... | Class II | ICU Medical, Inc. |
| May 11, 2026 | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... | There is the potential for leakage along the drug pathway from the pump through the end of the ca... | Class II | Boston Scientific Corporation |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 20, 2026 | navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navif... | Due to complaints received for the Image Management System regarding image/metadata discrepancy w... | Class II | Ventana Medical Systems, Inc. |
| Apr 14, 2026 | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Mar 24, 2026 | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
| Mar 24, 2026 | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extrav... | Medline has identified the presence of particulate within the fluid path of the Manifolds. | Class I | Medline Industries, LP |
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.