Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IIStop using Mentor CPX 4 tissue expanders
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DeviceMentor Texas, LP.Class IICheck your Mentor CPX 4 tissue expander infusion set
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using Philips Azurion 5 M20 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Azurion 5 M12 X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using Philips Azurion 7 M20 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Azurion 7 M12 X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using Philips Azurion 7 B20 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about your Azurion 7 B12 system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Azurion 3 M15 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Azurion 3 M12 X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper OR table foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about your Allura Xper X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20/20 OR Table
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20/20 X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper X-ray system
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about your ALLURA Xper FD10 table
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using Philips ALLURA Xper FD20 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips ALLURA X-ray tables
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips ALLURA X-ray systems
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using affected Philips X-ray foot switches
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips ALLURA Xper system serial number
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIStop using Philips ALLURA Xper FD10 foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips ALLURA X-ray foot switch
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about Allura Xper FD10C foot switch issue
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- 2026-04-08FDA-DeviceBD KIESTRA LAB AUTOMATIONClass IICheck BD Kiestra ReadA system connectivity
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
- 2026-04-08FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IICheck Siemens Atellica CH A1c_E test results
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.
- 2026-04-08FDA-DeviceReflexion Medical, Inc.Class IIContact RefleXion about X1 Radiotherapy System software update
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
- 2026-04-08FDA-DeviceReCor Medical Inc.Class IIDo not use ReCor Medical Paradise catheter
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- 2026-04-08FDA-DeviceReCor Medical Inc.Class IICheck Paradise renal denervation catheter lot M4907
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- 2026-04-08FDA-DevicePhilips Respironics, Inc.Class ICheck your Philips Respironics ventilator settings
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
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