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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
Patient support table floor plate may be incorrectly installed.
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material.