Class IOngoingZ-1470-2026
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 371 recalls
Class IOngoingZ-1469-2026
Abiomed, Inc. recalls Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Abiomed, Inc.MAMar 11, 2026
Class IIOngoingZ-1370-2026
Medica Corporation recalls Medica Capillary Tubes
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
Medica CorporationMAFeb 25, 2026
Class IIIOngoingZ-1337-2026
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Straumann USA LLCMAFeb 18, 2026
Class IIOngoingZ-1318-2026
Philips North America LLC recalls Spectral CT 7500 on Rails
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1317-2026
Philips North America LLC recalls Spectral CT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1316-2026
Philips North America LLC recalls IQon Spectral CT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1315-2026
Philips North America LLC recalls Brilliance iCT
As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification.…
Philips North America…MAFeb 18, 2026
Class IIOngoingZ-1314-2026
Hologic, Inc recalls 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.
Hologic, IncMAFeb 18, 2026
Class IIOngoingZ-1299-2026
FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if…
FUJIFILM Healthcare Am…MAFeb 11, 2026
Class IOngoingZ-1163-2026
Boston Scientific Corporation recalls *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new o…
Boston Scientific Corp…MAFeb 11, 2026
Class IOngoingZ-1162-2026
Boston Scientific Corporation recalls *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new o…
Boston Scientific Corp…MAFeb 11, 2026