Class IIOngoingZ-2190-2025
Boston Foundation For Sight recalls BostonSight SCLERAL Lens
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Boston Foundation For…MAAug 6, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 301–312 of 426 recalls
Class IOngoingZ-2164-2025
Abiomed, Inc. recalls Automated Impella Controller (AIC)
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Abiomed, Inc.MAAug 6, 2025
Class IIOngoingZ-2114-2025
NeuroSync, Inc. recalls NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 h…
Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.
NeuroSync, Inc.MAJul 23, 2025
Class IIOngoingZ-2101-2025
Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
Medtronic Navigation,…MAJul 16, 2025
Class IIOngoingZ-2034-2025
Philips North America LLC recalls Spectral CT. Computed tomography X-ray system.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performan…
Philips North America…MAJul 2, 2025
Class IIOngoingZ-2016-2025
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the…
Insulet CorporationMAJul 2, 2025
Class IIOngoingZ-1992-2025
Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Fresenius Medical Care…MAJun 25, 2025
Class IIOngoingZ-1966-2025
Belmont Instrument LLC recalls Allon 2001. Part Number: 200-00263
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1.…
Belmont Instrument LLCMAJun 18, 2025
Class IIOngoingZ-1936-2025
Philips North America recalls SmartPath to dStream for 1.5T¿
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire.…
Philips North AmericaMAJun 18, 2025
Class IIOngoingZ-1935-2025
Philips North America recalls Intera Achieva 1.5T Pulsar
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire.…
Philips North AmericaMAJun 18, 2025
Class IIOngoingZ-1934-2025
Philips North America recalls Intera 1.5T Omni/Stellar
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire.…
Philips North AmericaMAJun 18, 2025
Class IIOngoingZ-1933-2025
Philips North America recalls Intera 1.5T Master/Nova Product Number: 781106
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire.…
Philips North AmericaMAJun 18, 2025