Life2000 Ventilator System — Class I medical device recall Z-1139-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-03-08, distributed nationwide. There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 vent
| Recall number | Z-1139-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-01-25 |
| Classified | 2023-02-24 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 4,279 units |
| UPC / GTIN / UDI-DI | 00120270001450, 00120270001474, 00120280000221, 00120280000245, 00120280000344, 00120280000368, 00120280000382, 00120280000856, 00120280000894, 00120280000979, 00120290000549, 00120290000631, 00120290000648, 00120290000792, 00120290001089, 00120290001096, 00120290001195, 00120300000033, 00120300000040, 00120300000064, 00120300000071, 00120300000606, 00120300000613, 00120300000637, 00120300000644 and 272 more |
| Serial numbers | 120190000085, 120190000708, 120190000712, 120190000713, 120190001262, 120190001263, 120190001272, 120190001282, 120210000715, 120210000716, 120210000719, 120210000728, 120210000730, 120210000731, 120210000733, 120210000740, 120210000742, 120210000743, 120210000746, 120210000747, 120210000754, 120210000756, 12021000615, 120270001438, 120270001439 and 475 more |
| Model numbers | BT-20-0002, BT-20-0002A |
Product
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
Reason for recall
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
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-1139-2023. 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.