Class IIIOngoingZ-1623-2026
Philips Ultrasound, Inc recalls Philips OMNI II TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 133–144 of 621 recalls
Class IIIOngoingZ-1622-2026
Philips Ultrasound, Inc recalls Philips Mini Multi TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Class IIIOngoingZ-1621-2026
Philips Ultrasound, Inc recalls Philips L17-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Class IIIOngoingZ-1620-2026
Philips Ultrasound, Inc recalls Philips L12-5 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Class IIIOngoingZ-1619-2026
Philips Ultrasound, Inc recalls Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Class IIIOngoingZ-1618-2026
Philips Ultrasound, Inc recalls Philips 3D6-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PAApr 1, 2026
Class IIOngoingZ-1590-2026
GE Medical Systems, LLC recalls Imactis CT-Navigation System
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
GE Medical Systems, LL…WIApr 1, 2026
Class IOngoingZ-1588-2026
Navajo Manufacturing Company recalls Handy Solutions Neck & Shoulders Heating Pad
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense…
Navajo Manufacturing C…COApr 1, 2026
Class IIOngoingZ-1573-2026
Baxter Healthcare Corporation recalls Brand Name: Welch Allyn
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Baxter Healthcare Corp…ILMar 25, 2026
Class IIOngoingZ-1558-2026
Lutronic Corporation recalls CLARITY II Laser System
Reports of devices sparking/popping and potentially burning patients.
Lutronic CorporationMar 18, 2026
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