JAGTOME RX 39-30-260-025 Material Number: M00573100
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
All Recalls
95,025 total recalls in our database
JAGTOME RX 39-20-450-025 Material Number: M00573090
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
LivaNova Deutschland GmbH
🏥 Medical Devices Class I - Dangerous
One ferrite ring expected to be installed on centrifugal pump system power cable may not be present.
DREAMTOME 49-20MM/260CM Material Number: M00584000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
🏥 Medical Devices Class I - Dangerous
The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.
DREAMTOME 49-30MM/450CM Material Number: M00584030
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
JAGTOME RX 49-20-260-035 Material Number: M00573000
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
DREAMTOME 44-30MM/450CM Material Number: M00584070
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
🏥 Medical Devices Class I - Dangerous
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
LUMBAR PUNCTURE DRUG FREE TRAY 22G
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Sterility of device is compromised due to a sterile barrier breach
ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
🏥 Medical Devices Class I - Dangerous
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.