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 |
|---|---|---|---|---|
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
| Dec 12, 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead... | Class II | Philips North America Llc |
| Dec 12, 2025 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Hologic, Inc |
| Dec 11, 2025 | The product is used for the evaluation of the intrinsic coagulation pathway, ... | Potential for microbial contamination. | Class II | Instrumentation Laboratory |
| Dec 10, 2025 | MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a ... | Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical b... | Class II | REPLIGEN CORPORATION |
| Dec 5, 2025 | BVI Leos Laser and Endoscopy System. Model Number: OME6000U. | Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nu... | Class II | Beaver-Visitec International, Inc. |
| Dec 4, 2025 | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. | Device packaged in incorrect outer box carton. | Class II | Abiomed, Inc. |
| Dec 4, 2025 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 4, 2025 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (C... | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Mobius Imaging, LLC |
| Dec 3, 2025 | Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. 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 | Upgrade to MR 7700. Product Code (REF): 782130. 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 | 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 |
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.