Avanos Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1189-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.

Product Classification:

Class I

Date Initiated: February 3, 2023

Date Posted: March 22, 2023

Recall Number: Z-1189-2023

Event ID: 91663

Reason for Recall:

Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.

Status: Terminated

Product Quantity: 780 units

Code Information:

All lots are affected. Stock Code (Lot Number): B30511 (20098360), B30611 (20098361), B30711 (20097200), B30811 (20098362), B31011 (20098363).

Distribution Pattern:

US Nationwide distribution in the state of Oklahoma.

Voluntary or Mandated:

Voluntary: Firm initiated