AVANOS BALLARD Closed Suction System for Adults — Class II medical device recall Z-0360-2024
Ongoing recall by Avanos Medical, Inc., reported 2023-11-29. Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with
| Recall number | Z-0360-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2023-10-13 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Countries outside the US | ZA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00609038945064 |
| Lot numbers | 30112716, 30113925, 30116223, 30116495, 30116496, 30117487, 30117488, 30117632, 30117633, 30119101, 30119102, 30122179, 30122936, 30123991, 30124942, 30124946, 30126227, 30127429, 30127494, 30137504, 30151042, 30153170, 30194152 |
Product
AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0360-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.