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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

Vials may be cracked in affected lots.

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

Affected lot exceeds concentration limit for N-nitrosodimethylamine (NDMA) at the 48-month stability testing timepoint.

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…

Presence of particulate matter in affected lot.

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…

Affected lot may result in a false negative for skin test (peanut allergy).