An FDA-recorded root-cause determination. The FDA lists 22 recalls with this root cause since 2025. Most recent report: Jun 17, 2026.
Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
The device does not bear a unique device identifier.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.