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During our global market surveillance activities, we have become aware of cases in which the software on the Infinity® Central Station drops peaks on narrow waveforms causing the Infinity® M300 to fail the requirements of the standard IEC 60601-2-27.…

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Recall start date: March 1, 2023

It was identified by Medtronic that an incorrect type of titanium was used for the manufacturing of subcomponents of multi-axial screws that are for use as part of the Infinity oct system. This incorrect material reduces the clamping strength of the…

Specific lots have the potential for a broken sled vane component. A broken sled vane may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may…

Baxter Corportation is issuing a recall for certain lots of the Minicap. These devices are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.  Recall start date: February 01, 2023

Through ongoing internal testing, Baxter Corporation has observed isolated incident of over infusion on the Novum IQ LVP infusion pump during test runs at 0.1 ml/hr after 40 hours of continuous infusion within the 96-hour set change interval. Baxter…

In case the magnets of the Novastar TS and Novastar Plus are positioned near medical devices (implanted as well as not-implanted) and metallic implants the magnetic field might impact the implants or devices and cause serious injury. Recall start date…

Medline Industries, LP is recalling custom procedure packs containing medtronic non-absorbable sutures due to a manufacturing error in the packaging of the sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier…

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 replacement silicone sound abatement foam installed into the Trilogy 100 and Trilogy 200 devices identified in this letter may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air…

Philips has identified an issue where a specific component failure in the gradient coil of where the affected 3T MR Systems identified above may act as a heat source, with a potential to produce smoke and/or fire.  If the components failure…

Infolding is a known phenomenon and occurs when the valve frame folds inward along a vertical line away from the valve inflow and appears as a seam in the frame or as overlapping frame cells on radiographic imaging. Infolding is different and distinct…

Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier…

Teleflex has initiated a voluntary field safety corrective action due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an ac power source…

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six…