Class IIOngoingZ-1581-2026
Elekta, Inc. recalls Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion L…
Due to adapter not being properly aligned or locked in place.
Elekta, Inc.GAMar 25, 2026
Recalls: Use error
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 44 recalls
Class IIOngoingZ-1498-2026
Raz Design Inc recalls Raz-AT (Attendant Tilt) Mobile Shower Commode Chair
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Raz Design IncMar 18, 2026
Class IIOngoingZ-1340-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1339-2026
Elekta, Inc. recalls Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system…
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.…
Elekta, Inc.GAFeb 18, 2026
Class IIOngoingZ-1048-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Emphasizing instructions for LVP duration programming located in the IFU.
Fresenius Kabi USA, LL…MAJan 21, 2026
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
Class IIOngoingZ-0864-2026
Philips North America LLC recalls IntelliVue Patient Monitor MX500. Product Number: 866064.
Potential issue where the IntelliVue monitors did not alarm.
Philips North America…MADec 10, 2025