Class IIIOngoingZ-2348-2025
Philips Ultrasound, Inc recalls 7.5MHZ Endo Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,273–1,284 of 2,908 recalls
Class IIIOngoingZ-2347-2025
Philips Ultrasound, Inc recalls 3D9-3v Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
Class IIIOngoingZ-2346-2025
Philips Ultrasound, Inc recalls 3D6-2 Transducer Probe
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips Ultrasound, In…PASep 3, 2025
Class IOngoingZ-2343-2025
Tandem Diabetes Care, Inc. recalls Battery Operated infusion pumps. t:slim X2 G5
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a…
Tandem Diabetes Care,…CASep 3, 2025
Class IIOngoingZ-2342-2025
GE Medical Systems, LLC recalls GE HealthCare OEC 9900 Elite C-arm Systems.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems.…
GE Medical Systems, LL…WISep 3, 2025
Class IIOngoingZ-2341-2025
GE Medical Systems, LLC recalls GE HealthCare OEC 9800.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems.…
GE Medical Systems, LL…WISep 3, 2025
Class IIOngoingZ-2345-2025
Dynex Technologies, Inc. recalls Dynex Agility Sample Tips
The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with…
- Labeled Or Promoted For A Specific Medical Use General Purpose Laboratory Equipment
- Labeling Change Control
Dynex Technologies, In…VAAug 27, 2025
Class IIOngoingZ-2344-2025
LUMENIS, LTD. recalls OtoLase Starter Kit
The potential for unsterilized product within finished product labeled as sterile.
LUMENIS, LTD.Aug 27, 2025
Class IIOngoingZ-2340-2025
Boston Scientific Neuromodulation Corporation recalls Burr Hole Cover Kit
Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural del…
Boston Scientific Neur…CAAug 27, 2025
Class IIOngoingZ-2339-2025
Olympus Corporation Of The Americas recalls Electrosurgical
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Olympus Corporation of…PAAug 27, 2025
Class IIOngoingZ-2338-2025
Olympus Corporation Of The Americas recalls Electrosurgical
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Olympus Corporation of…PAAug 27, 2025
Class IIOngoingZ-2337-2025
Mckesson Medical-Surgical Inc. Corporate Office recalls Clearview Strep A Exact II Dipstick Respiratory Kit
Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Mckesson Medical-Surgi…VAAug 27, 2025