Recall database

Recalls: Component change control

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 25–26 of 26 recalls

Class IIOngoingZ-1876-2026

Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes…

Unapproved design changes to the products outside of the 510(k) clearance.

Angiography/Angioplasty Kit
Component change control

Medline Industries, LPILApr 29, 2026

Class IIOngoingZ-1793-2026

Spacelabs Healthcare, Inc. recalls Multi-parameter Command Module

Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO mea…

Arrhythmia Detector And Alarm
Component change control

Spacelabs Healthcare,…WAApr 15, 2026