Company: Howmedica Osteonics Corp. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED...Read More

Company: ICU Medical, Inc. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 Recall Number: Z-0966-2026 REASON: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/19/2025 Class: II PRODUCT BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro...Read More