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Smith Medical has issuing a recall of its Logical 3 Gang Manifold due to potential defect with the rotating   adaptor(rotator) which is incorporated as a component within the product. It was identified that the inner diameter of the device's o-ring…

Potential for a small open channel in the lift and peel aluminum seal resulting in a compromised sterile barrier, potential for a lack of sterility assurance. Recall start date: November 13, 2023

Stryker received one (1) complaint for a LITe Decompression Tube Snake Arm that did not fit on to the arm post shaft that mounts to the hospital bed. Subsequent investigation determined a portion of one lot of the LITe Decompression Tube Snake Arm was…

When processing specific patient plasma specimens with the Aptima® CMV Quant Assay, a ML2 error flag may occur, which will invalidate specimens within the assay run. Recall start date: November 20, 2023

During an evaluation of user implementation of the instructions for use related to the reprocessing of the LTF-S190-5 videoscope, Olympus observed deviations from the following reprocessing steps detailed in the respective reprocessing manual…

Upon insertion of a new (unused) Ligasure™ device, the Valleylab™ FT10 energy platform running software versions 4.0.1, 4.0.2 and 4.0.3 may erroneously indicate that the Ligasure™ device was used previously. When this occurs, the energy platform will…

Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the vesa holder of the aCart™ compact, due to incorrect length screws used penetrating the lithium-ion battery of the device. Investigations have…

Medtronic recently identified that if the Synchromed II Pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI…

Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving the devices, as well as reports of bursting and leaking. Olympus has received reported adverse events involving foreign body…

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices.…

Our recent interference testing has shown that the presence of lubricants in the vaginal specimen may interfere with the prom test result, which deviates from what is presented in the instructions for use. The defectiveness was discovered 2023-11-08.…

In June 2023, due to market disruptions outside of our control, Cardinal Health changed the supplier for the cotton used to manufactur Webril™ Undercast Padding. Although the Webril™ Cotton Undercast Padding continues to meet product specifications,…

The quality issue under investigation is applicable to the "connection cable venous probe, l0.23m".  The part causing the nonconformance under investigation is responsible for data transmission between the Cardiohelp-i and the venous probe. A…

The impurity free salicylic acid is out of specification in the affected batches.

Smiths Medical has identified a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the device's o-ring may be oversized affecting seal integrity. Recall Start Date: November 9, 2023