Volara System — Class I medical device recall Z-2321-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-07-24, distributed nationwide. Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handse
| Recall number | Z-2321-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-05-30 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR |
| Quantity | 58,220 units |
| Lot numbers | 2171WA, 2237WA, 2238WA, 2241WA, 2242WA, 2243WA, 2244WA, 2249WA, 2250WA, 2251WA, 2285WA, 2286WA, 2290WA, 2297WA, 2298WA, 2299WA, 2307WA, 2308WA, 2311WA, 2332WA, 2333WA, 2341WA, 2342WA, 2349WA, 2355WA, 2356WA, 2357WA, 2363WA, 2364WA, 3019WA, 3061WA, 3067WA, 3068WA, 3069WA, 3072WA, 3073WA, 3074WA, 3080WA, 3081WA, 3094WA and 40 more |
Product
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Reason for recall
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
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-2321-2024. 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.