Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 — Class II medical device recall Z-0813-2022
Ongoing recall by Outset Medical, Inc., reported 2022-03-30, distributed nationwide. Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur
| Recall number | Z-0813-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Outset Medical, Inc., San Jose, CA, United States |
| Recall initiated | 2022-01-20 |
| Classified | 2022-03-21 |
| Reported by FDA | 2022-03-30 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00850001011112, 00850001011204 |
| Serial numbers | 400025, 400026, 400027, 400028, 400032, 400034, 400035, 400036, 400038, 400039, 400040, 400041, 400042, 400043, 400044, 400045, 400046, 400047, 400048, 400050, 400051, 400052, 400054, 400056, 400057 and 475 more |
| Model numbers | PN-0003000, PN-0006000 |
Product
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Reason for recall
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
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-0813-2022. 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.