Class IIIOngoingZ-0938-2026
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
Instrumentation Labora…MADec 24, 2025
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 193–204 of 426 recalls
Class IIOngoingZ-0936-2026
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Fresenius Medical Care…MADec 24, 2025
Class IOngoingZ-0885-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Fresenius Kabi USA, LL…MADec 24, 2025
Class IIOngoingZ-0597-2026
Philips North America recalls Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FL…
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer.…
Philips North AmericaMADec 17, 2025
Class IIOngoingZ-0882-2026
Philips North America LLC recalls CT 5300
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during…
Philips North America…MADec 10, 2025
Class IIOngoingZ-0881-2026
Philips North America LLC recalls Incisive CT
If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during…
Philips North America…MADec 10, 2025
Class IIOngoingZ-0870-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX850. Product Number: 866470.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0869-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0868-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX750. Product Number: 866471.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0867-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX700. Product Number: 865241.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0866-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX600. Product Number: 865242.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025
Class IIOngoingZ-0865-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX550. Product Number: 866066.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025