Browse Device Recalls
3,494 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,494 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 3,494 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 21, 2026 | CRE Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Wireguided 8-10mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 15-18mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 10-12mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 21, 2026 | CRE Pro Wireguided 12-15mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | Class II | Boston Scientific Corporation |
| May 20, 2026 | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 19, 2026 | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector pane... | Class II | Medtronic Navigation, Inc.-Boxborough |
| May 18, 2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... | Class I | Abiomed, Inc. |
| May 14, 2026 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| May 12, 2026 | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-5... | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water a... | Class II | Boston Scientific Corporation |
| May 12, 2026 | Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-... | Given the increased number of leaks reported by users, it was determined to be the appropriate c... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 11, 2026 | 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers a... | Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 500... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premie... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQ... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 7, 2026 | Bicarby Dialysate; Model number: RFP-400-G; | There is an error in the labeling of the GTIN on the product. When scanned; however, the case lab... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 6, 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typica... | Class I | Fresenius Kabi USA, LLC |
| May 5, 2026 | Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. | Software anomaly that causes a false display of error code 5018. | Class II | IPG Medical Corporation |
| May 1, 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to pr... | Class II | Philips North America Llc |
| Apr 29, 2026 | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm A... | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mah... | Class II | Mozarc Medical US LLC |
| Apr 20, 2026 | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | A retrospective review identified that there are AIC units requiring specific hardware updates to... | Class I | Abiomed, 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 Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... | The potential for stiffness value errors when a specific range of image reconstruction parameters... | Class II | Philips North America |
| Apr 14, 2026 | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... | 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 |
| Apr 8, 2026 | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 8, 2026 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, S... | Complaints have been received of systems developing loose, missing, or broken internal bolts over... | Class II | Hologic, Inc |
| Apr 2, 2026 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens... | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mT... | Class II | Siemens Healthcare Diagnostics Inc |
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.