Medical device recalls

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.

Sterility assurance with procedure trays

Sterility assurance with procedure trays

Sterility assurance with procedure trays

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

The hardness not meeting the material specification and may cause the diamond bur to bend.

Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.