Class II — Outset Medical, Inc.
| Recalling firm | Outset Medical, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. |
| Product | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 |
| Quantity | 1,123 systems (PN-0003000) and 1,487 (PN-0006000) |
| Distribution | U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY. |
| Initiated | 2022-01-20 |
| Classified | 2022-03-21 |
| Recall number | Z-0813-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Outset Medical, Inc. (Z-0813-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89616/
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