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 |
|---|---|---|---|---|
| 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 |
| Oct 7, 2025 | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture... | Class II | NeuroLogica Corporation |
| Oct 6, 2025 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE ... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Ca... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 1, 2025 | Automated Impella Controller (AIC), used for left heart support blood pump, l... | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella ... | Class I | Abiomed, Inc. |
| Sep 25, 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 22, 2025 | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (S... | The potential for falsely depressed Intact PTH patient results at the low end of the assay range,... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 16, 2025 | Automated Impella Controller (AIC) labeled as the following with correspondin... | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... | Class I | Abiomed, Inc. |
| Sep 15, 2025 | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... | It was found that the shaft for mounting the X-ray tube unit on the support may break. In additio... | Class II | FUJIFILM Healthcare Americas Corporation |
| Sep 12, 2025 | Cardiac Workstation 7000; Model Number: 860441; | Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... | Class II | Philips North America |
| Sep 12, 2025 | Cardiac Workstation 5000; Model Number: 860439; | Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... | Class II | Philips North America |
| Sep 11, 2025 | CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | The failure occurs if a user on the Omnipod 5 iOS application selects and hol... | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual ... | Class II | Insulet Corporation |
| Sep 11, 2025 | LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C... | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | TENACIO Pump with InhibiZone; UPN: 72404429; | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 11, 2025 | TENACIO Pump without InhibiZone; UPN: 72404420; | The potential for devices to experience inflation and/or deflation performance issues or difficul... | Class II | Boston Scientific Corporation |
| Sep 3, 2025 | Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. | Potential issue that can cause the device to register "phantom" touches in the lower-left corner ... | Class II | Fresenius Kabi USA, LLC |
| Aug 29, 2025 | Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F16... | To provide further information to the user to ensure proper use of the medical device. the caps h... | Class II | Fresenius Medical Care Holdings, Inc. |
| 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 20, 2025 | Automated Impella Controller (AIC) with the below brands and product codes. U... | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not mee... | Class I | Abiomed, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America 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.