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Results of post market surveillance revealed that under certain circumstances the room configuration parameters of the system are set to default values. If these values are larger than the actual room dimensions, a collision with the ceiling or wall…

Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health™ Channel wound drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound…

Boston Scientific (BSC) initiated a field action in October 2022, communicating that remnant orise gel post-procedure can cause a foreign body reaction, appearing as mass formations and submucosal distortions. Since this time, BSC has become aware of…

Two complaints were received from China in which ball bearings in the Crani-a (anspach power tools adult craniotome attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Exact circumstances are unknown.…

For certain nuclear medicine systems, GE Healthcare has become aware that a mitigation may not be correctly implemented. If this is the case, the detector can fall leading to life-threatening bodily injury. Recall start date: December 18, 2022

The option ''rejection of external orders'' is not working as expected in Cobas Infinity Central Lab when specific pre-conditions are met simultaneously which may lead to mismatch of sample tube ID. In Canada, none of the customers are using the impacted…

Siemens Healthcare is informing customers with a preventive measure to exclude any potential risk of patient injury caused the footrest detaching from the patient table during an examination. Recall start date: December 15, 2022

Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system. 1.    systems which had their ADU's serviced may have an incorrect boardvalue (calibration…

Siemens Healthcare Diagnostics Inc. has confirmed an issue through complaint investigation. The issue has the potential to affect the recovery of po2 in quality control (qc) at elevation with barometric pressures <730 mmhg on epoc sensor configuration…

There is a potential that Cadd-legacy pumps may not detect that 50 ml and 100 ml Cadd medication cassette reservoirs with flow stop are attached to the pump when the cassettes are properly attached. This issue does not impact 250 ml flow-stop and non-…

Stryker is notifying airo truct customers that we will be highlighting certain information that is already in the airo truct user manual on labels affixed to the airo truct unit itself. Stryker received one report of an injury to an untrained user that…

The most recent lot of BC-3D distributed, lot b1122, normal level may exhibit hemolysis or deterioration due to a microbial contamination. Recall start date: December 5, 2022

During the production process, a potential internal leaking condition within the hub of specific Mahurkar acute dual lumen high flow  hemodialysis catheter was identified as a result of a void in the catheter hub. During dialysis, this observed…

Zimmer Biomet is conducting a medical device recall for Nexgen stemmed cemented option tibial trays due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the legacy posterior…

Teleflex has initiated a voluntary field safety corrective action due to reports of pilot balloon non-inflation or cuff non-deflation. In the event of pilot balloon non-inflation, there is a potential risk of injury to the patient as the pilot balloon no…