🏥 Medical Devices Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).
🏥 Medical Devices Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.
BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
🏥 Medical Devices Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
🏥 Medical Devices Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
🏥 Medical Devices Class I - Dangerous
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Biodex Medical Systems
🏥 Medical Devices Class I - Dangerous
When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
🏥 Medical Devices Class I - Dangerous
Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.
🏥 Medical Devices Class I - Dangerous
There is a potential for distal end of catheters to fracture and become detached.
🏥 Medical Devices Class I - Dangerous
Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical
🏥 Medical Devices Class I - Dangerous
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
🏥 Medical Devices Class I - Dangerous
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.