VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Greiner Bio-One North America
🏥 Medical Devices Class I - Dangerous
Blood collection tubes may experience a clotting issue.
All Recalls
95,025 total recalls in our database
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
🏥 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.
PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Aesculap Implant Systems
🏥 Medical Devices Class I - Dangerous
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
AMX Navigate Mobile X-Ray System
GE Healthcare
🏥 Medical Devices Class I - Dangerous
An unexpected column motion while attempting to park the column on the AMX Navigate mobile X-ray system.
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Angiodynamics Inc. (Navilyst Medical Inc.)
🏥 Medical Devices Class I - Dangerous
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
🏥 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
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.