🏥 Medical Devices Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
All Recalls
95,114 total recalls in our database
LoFric Origo, Tiemann, 16in, FR14 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
🏥 Medical Devices Class I - Dangerous
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Mevion Medical Systems
🏥 Medical Devices Class I - Dangerous
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
🏥 Medical Devices Class I - Dangerous
During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Thora-Para 5 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
🏥 Medical Devices Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
🏥 Medical Devices Class I - Dangerous
The needle surface deteriorated due to unexpected electrolysis during procedure.
LoFric Origo, Nelaton, 16in, FR10 urinary catheters
Wellspect HealthCare (Division of DENTSPLY IH AB)
🏥 Medical Devices Class I - Dangerous
Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
Safe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
🏥 Medical Devices Class I - Dangerous
The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5.
Safe-T-Centesis 8 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Safe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
🏥 Medical Devices Class I - Dangerous
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
🏥 Medical Devices Class I - Dangerous
Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
🏥 Medical Devices Class I - Dangerous
Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Thora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Safe-T-Centesis 6 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Thora-Para 8 Fr Catheter Drainage Tray
Carefusion 2200
🏥 Medical Devices Class I - Dangerous
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.