Medical Device Recalls since June 26, 2025

ProScreen 8 Panel Dip Card, Item No. PSD-8P

ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300

ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M

ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX

Airways Development LLC WaterPAP Positive Airway Pressure Device Made in the USA, Airways Development LLC 740 Jefferson Avenue, Suite B, Kenilworth, NJ 07033

Artis systems with large display from Siemens Medical Solutions USA, Inc.

Cardinal Health Tiny Toes; 11470-010T

MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. The staple line length is 30 mm long. The Stapler can be loaded, fired, and reloaded with the MicroCutter XCHANGE 30 Cartridge for up to the number deployments indicated on package label in a single surgical procedure. The Stapler can fire different sized staples, with the size of the staple indicated by the color of the MicroCutter XCHANGE Cartridges. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

Ingenuity CT Computed Tomography X-ray system

Brilliance iCT SP Computed Tomography X-ray system

Ingenuity Core 128 Computed Tomography X-ray system

MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.

Brilliance iCT Computed Tomography X-ray system

Ingenuity Core Computed Tomography X-ray system

Brilliance 64 Computed Tomography X-ray system

Terumo Surflo Winged Infusion Set with Filter and Needle Protection, Rx Only, Sterile Terumo Europe NV Interleuvenlaan 40, 3001 Leuven, Belgium

Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

Merge Cardio with software version 10.1 LA.

GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.

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