Class IIOngoingZ-2561-2025
Exactech, Inc. recalls Exactech Equinoxe
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Exactech, Inc.FLSep 24, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,057–1,068 of 2,908 recalls
Class IIOngoingZ-2560-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J du…
Ortho-Clinical Diagnos…NYSep 24, 2025
Class IIOngoingZ-2559-2025
Ortho-Clinical Diagnostics, Inc. recalls Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartr…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J du…
Ortho-Clinical Diagnos…NYSep 24, 2025
Class IIOngoingZ-2558-2025
Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location.…
Boston Scientific Neur…CASep 24, 2025
Class IOngoingZ-2540-2025
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunct…
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Max Mobility LLCTNSep 24, 2025
Class IOngoingZ-2539-2025
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjuncti…
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Max Mobility LLCTNSep 24, 2025
Class IOngoingZ-2538-2025
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunctio…
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
Max Mobility LLCTNSep 24, 2025
Class IOngoingZ-2483-2025
3M Company recalls 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355
Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet temperature for Ranger Blood/Fluid Warming High Flow Sets.
3M CompanyMNSep 24, 2025
Class IIOngoingZ-2557-2025
Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device
Failure of fusion system instruments in the field.
Omnia MedicalWVSep 17, 2025
Class IIOngoingZ-2556-2025
Omnia Medical recalls TiBrid Stand Alone Intervertebral Body Fusion Device
Failure of fusion system instruments in the field.
Omnia MedicalWVSep 17, 2025
Class IIOngoingZ-2555-2025
Orthofix U.S. LLC recalls PILLAR SA Ti
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box.…
Orthofix U.S. LLCTXSep 17, 2025
Class IIOngoingZ-2554-2025
SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative…
SEASPINE ORTHOPEDICS C…CASep 17, 2025