Class IIOngoingZ-1558-2026
Lutronic Corporation recalls CLARITY II Laser System
Reports of devices sparking/popping and potentially burning patients.
Lutronic CorporationMar 18, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 109–120 of 588 recalls
Class IIOngoingZ-1494-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: Shoc…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1479-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy S…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1478-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotr…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1477-2026
Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithot…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
Olympus Corporation of…PAMar 11, 2026
Class IIOngoingZ-1475-2026
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on sy…
GE HealthcareILMar 11, 2026
Class IIOngoingZ-1351-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M20 System Model Numbers: (1)722228
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026
Class IIOngoingZ-1350-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M12 System Model Numbers: (1)722227
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026
Class IIOngoingZ-1349-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 System Model Numbers: (1)722079
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026
Class IIOngoingZ-1348-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026
Class IIOngoingZ-1347-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20 System Model Numbers: (1)722068
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026
Class IIOngoingZ-1346-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12 System Model Numbers:(1) 722067
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
PHILIPS MEDICAL SYSTEM…Feb 18, 2026