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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates.
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Potential contamination of the product with latex adhesive residual.
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. 1010.2 in that they currently do not bear the required certification label.
The guide tip can become damaged and result in the tip detaching.
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. 1010.2 in that they currently do not bear the required certification label.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.