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 |
|---|---|---|---|---|
| Mar 12, 2024 | Intera 1.5T Achieva IT Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Achieva Nova, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | GYROSCAN T5-NT, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 3.0T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Intera 1.5T Omni/Stellar, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Achieva 1.5T, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 12, 2024 | Ingenia 1.5T S, Magnetic Resonance System. | Patient support table floor plate may be incorrectly installed. | Class II | Philips North America Llc |
| Mar 11, 2024 | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed... | Class II | Conformis, Inc. |
| Mar 11, 2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the met... | System error messages may delay the ability to test patient samples and the need for frequent cal... | Class II | Advanced Instruments, LLC |
| Mar 7, 2024 | LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. | Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy ... | Class I | Fresenius Kabi USA, LLC |
| Feb 28, 2024 | Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX ... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 28, 2024 | CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent... | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play c... | Class II | Philips North America |
| Feb 23, 2024 | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... | Class II | Magellan Diagnostics, Inc. |
| Feb 21, 2024 | Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 21, 2024 | Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulat... | InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential... | Class I | InfuTronix LLC |
| Feb 20, 2024 | EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition dir... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition d... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutri... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nut... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 20, 2024 | EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutr... | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen... | Class II | Boston Scientific Corporation |
| Feb 15, 2024 | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX syst... | If the DIVA touch display generates touch inputs without user interaction, due to possibility of ... | Class II | Philips North America Llc |
| Feb 2, 2024 | BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... | Pack and pouch label is missing the manufacturing and expiration date. | Class II | Beaver Visitec International, Inc. |
| Jan 29, 2024 | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessor... | Product is recalled due to reports of blood leaking or spraying from the arterial line on the car... | Class II | NxStage MDS Corporation |
| Jan 26, 2024 | Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a b... | This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inv... | Class II | EMD Millipore Corporation |
| Jan 23, 2024 | stay-safe /Safe Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 12 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Catheter Ext. 6 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Catheter Ext. 18 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 23, 2024 | stay-safe /Luer Lock Adapter 4 in | The peroxide cross-linked tubing has leachables identified as NDL PCBAs. | Class I | Fresenius Medical Care Holdings, Inc. |
| Jan 10, 2024 | Synapse PACS - Version 7.2.200 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.3.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000US | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.1.000 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 10, 2024 | Synapse PACS - Version 7.2.100 | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM heade... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera Achieva 1.5T Pulsar. Model (REF) Number 781171. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Achieva 1.5T Initial system. Model (REF) Numbers 781178. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse CV 6. with AR. A web-based application as the primary user interfa... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Achieva XR. Model (REF) Numbers 781153, 781253. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application a... | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the ma... | Class II | FUJIFILM Healthcare Americas Corporation |
| Jan 3, 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782... | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
| Jan 3, 2024 | Intera 1.5T Achieva Nova. Model (REF) Numbers 781172. | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... | Class II | Philips North America |
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.