Avanos Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1190-2023)

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, Elbow Manifold.

Product Classification:

Class I

Date Initiated: February 3, 2023

Date Posted: March 22, 2023

Recall Number: Z-1190-2023

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: 220 units

Code Information:

All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).

Distribution Pattern:

US Nationwide distribution in the state of Oklahoma.

Voluntary or Mandated:

Voluntary: Firm initiated