🏥 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
95,018 total recalls in our database
🏥 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.
BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
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
Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
🏥 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.
Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
🏥 Medical Devices Class I - Dangerous
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
🏥 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
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.
The flow sensors built prior to June 2021 could have damaged tubes with small punctures or cuts that could cause leaks resulting in incorrect anesthesia machine tidal volumes potentially leading to over-delivery of volume to the patient.
BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
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."
ElliptiGO Arc bicycles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bicycle frame can break while riding, posing fall and injury hazards to the user.
White Wood Stools
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The stools can break during use, posing fall and injury hazards.
🍎 Food Class I - Dangerous
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.
🍎 Food Class I - Dangerous
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.
🍎 Food Class I - Dangerous
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.
🍎 Food Class I - Dangerous
Undeclared sulfites
🍎 Food Class I - Dangerous
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.
🍎 Food Class I - Dangerous
The firm determined that the food was not held at an appropriate temperature. Because of the time-temperature relationship of the environment this food could be unsafe to consume.