Browse Device Recalls
3,376 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,376 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 3,376 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 3, 2025 | Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR syst... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW ve... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. ... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW v... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR s... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW versio... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Dec 3, 2025 | SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems wit... | The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness ma... | Class II | Philips North America |
| Nov 24, 2025 | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. | Removal of affected lot of screws due to labeling error. | Class II | Smith & Nephew, Inc. |
| Nov 21, 2025 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | Class II | Fresenius Kabi USA, LLC |
| Nov 18, 2025 | HemosIL SynthAFax. Partial Thromboplastin Time Tests. | Recalled lots were manufactured with double the amount of preservative concentration. | Class III | Instrumentation Laboratory |
| Nov 14, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont... | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious pa... | Class I | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbi... | Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious... | Class I | Fresenius Kabi USA, LLC |
| Nov 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a chec... | Class II | Fresenius Kabi USA, LLC |
| Oct 31, 2025 | IntelliVue MP70. Product Number: M8007A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX450. Product Number: 866062. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX750. Product Number: 866471. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX550. Product Number: 866066. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Multi-Measurement Module X3. Product Number: 867030. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX400. Product Number: 866060. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX600. Product Number: 865242. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP20. Product Number: M8001A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP5. Product Number: M8105A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP60. Product Number: M8005A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Multi Measurement Server X2. Product Number: M3002A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP40. Product Number: M8003A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX100. Product Number: 867033. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP80. Product Number: M8008A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP50. Product Number: M8004A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP2. Product Number: M8102A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX850. Product Number: 866470. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX500. Product Number: 866064. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX700. Product Number: 865241. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue Patient Monitor MX800. Product Number: 865240. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP30. Product Number: M8002A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 31, 2025 | IntelliVue MP90. Product Number: M8010A. | Potential issue where the IntelliVue monitors did not alarm. | Class II | Philips North America Llc |
| Oct 29, 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci... | Class II | Philips North America Llc |
| Oct 29, 2025 | CT 5300; Software Version Number: 4.5, 5.0, 5.1; | If the screws of tube heat exchanger on the rotating scanner are not tightened well after replaci... | Class II | Philips North America Llc |
| Oct 27, 2025 | Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVE... | Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped ... | Class II | Philips North America |
| Oct 25, 2025 | 5008X CAREsystem +CLiC +CDX; | Several software anomalies with the potential to impact patient treatment, of which one includes ... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | The possibility for this product that is intended for demonstration purposes only to be placed in... | Class II | Straumann USA LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
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.