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Zimmer GmbH is conducting a medical device field safety corrective action (removal) for one lot of the NCB femoral screws. The product in scope is part of a mix-up with a NCB humeral screw that differs in dimensions and therefore it has been decided to…

During a specific servicing activity, if the wrong screws are removed by the service personnel without the appropriate table supports in place, there is the potential for the table to drop. Recall start date: June 6, 2022…

During an internal review, it was determined that the Cathcart head includes a +5mm offset, which was not specified in previous versions of the self-centering bipolar and Modular Cathcart unipolar endo heads surgical technique…

Hillrom received reports of mislabeled fiberoptic Mac #1 laryngoscope blades (p/n 69061 lot 21-056). The outer box label stated Mac #1 laryngoscope blades (p/n 69061), but actually contained Mac #2 laryngoscope blades (p/n…

Ambu has received complaints on Vivasight 2 Dlt concerning leak/rupture of either the bronchial or tracheal cuff. Leakage occurred during procedure could potentially lead to loss of secure airway and will require re-intubation…

GE Healthcare has become aware of two issues related to a potential to display inaccurate measurements on images in centricity universal view Zero Footprint Client (zfp). Recall start date: June 9, 2022…

Alere San Diego has identified that bilirubin interference level listed in the package insert is incorrect. Concentrations less than 5.0 mg/dl can impact the accuracy of triglyceride (TRG) and High-density lipoproteins (HDL). Bilirubin levels of 2.0 mg/…

Medtronic has identified a potential leaking condition within the hub of specific chronic hemodialysis catheters. Flushing one extension tube may result in unanticipated fluid return through the adjacent extension tube (in addition to the anticipated…

Siemens Healthcare Diagnostics Inc. has confirmed the occurrence of inconsistent discrepant (low bias) po2 results. at a medical decision level of approximately 80mmhg, the maximum negative bias is - 11.7% (the acceptable bias is +/-10% for po2 range 50-…

This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to…

Zeltiq Aesthetics, Inc. is voluntarily discontinuing and recalling Coolsculpting parallel plate applicators (Coolcore, Coolcurve, Coolcurve+, Coolmax, and Coolfit applicators) due to the observance of a slightly increased rate of paradoxical hyperplasia…

During a specific servicing activity, if the wrong screws are removed by the service personnel without the appropriate table supports in place, there is the potential for the table to drop. Recall start date: June 6, 2022

Operators may see an incorrect orientation of images during the first exam upon system start. due to an issue in the firmware of the wallstand vs2 board, the system will rotate the amplimat field selection by 90 degrees. The anatomic position markers…

Potential reversal of o2 and air cyclinder pressure transducer connections. Recall start date: June 3, 2022

An error associated with the operating system causes this defect. After approximately 25 days of continuous use, technical alarm escalation does not occur as specified and expected. All clinical alarms functions as intended and…