Avanos Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0360-2024)

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:

AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation

Product Classification:

Class II

Date Initiated: October 13, 2023

Date Posted: November 29, 2023

Recall Number: Z-0360-2024

Event ID: 93305

Reason for Recall:

Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product did contain DEHP.

Status: Ongoing

Product Quantity: 4730 cases (94600 devices)

Code Information:

UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991

Distribution Pattern:

US and South Africa

Voluntary or Mandated:

Voluntary: Firm initiated