Class IIOngoingZ-3030-2026
FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7.4.310
Software issue may cause the ruler measurement to be inaccurate.
FUJIFILM Healthcare Am…MASep 2, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 415 recalls
Class IIOngoingZ-3017-2026
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
Fresenius Medical Care…MASep 2, 2026
Class IIOngoingZ-2976-2026
Siemens Healthcare Diagnostics, Inc. recalls Beckman Coulter
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi…
Siemens Healthcare Dia…MAAug 26, 2026
Class IIOngoingZ-2975-2026
Siemens Healthcare Diagnostics, Inc. recalls Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, includi…
Siemens Healthcare Dia…MAAug 26, 2026
Class IIOngoingZ-2967-2026
Paragonix Technologies Inc. recalls Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-800…
Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservation parameters.
Paragonix Technologies…MAAug 26, 2026
Class IIOngoingZ-2962-2026
Boston Scientific Corporation recalls Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2961-2026
Boston Scientific Corporation recalls OverStitch Suture Cinch
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Boston Scientific Corp…MAAug 26, 2026
Class IIOngoingZ-2956-2026
Philips North America LLC recalls Cardiac Workstation 7000. Product Number: 860441.
Device will intermittently provide inaccurate data related to native heart rate.
Philips North America…MAAug 26, 2026
Class IIOngoingZ-2955-2026
Philips North America LLC recalls Cardiac Workstation 5000. Product Number: 860439.
Device will intermittently provide inaccurate data related to native heart rate.
Philips North America…MAAug 26, 2026
Class IIOngoingZ-2951-2026
Foundation Medicine, Inc. recalls Hamilton Microlab STAR Liquid Handler
Software issue that can cause an increase in spontaneous software closures.
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Software design
Foundation Medicine, I…MAAug 26, 2026
Class IIOngoingZ-2935-2026
Straumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
Straumann USA LLCMAAug 19, 2026
Class IIOngoingZ-2933-2026
OBP Medical Corporation recalls OBP Medical
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
OBP Medical Corporatio…MAAug 19, 2026