Tablo Console — Class II medical device recall Z-0019-2025
Ongoing recall by Outset Medical, Inc., reported 2024-10-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, sp
| Recall number | Z-0019-2025 |
|---|---|
| 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 | 2024-08-01 |
| Classified | 2024-10-03 |
| Reported by FDA | 2024-10-09 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AE |
| Quantity | 2,422 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00850001011112, 00850001011204 |
| Serial numbers | 400048, 400058, 400063, 400082, 400087, 400109, 400141, 400205, 400222, 400227, 400288, 400317, 400347, 400394, 400405, 400412, 400424, 400425, 400432, 400440, 400463, 400487, 400849, 400916, 400981 and 475 more |
| Model numbers | PN-0003000, PN-0006000 |
Product
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Reason for recall
Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
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-0019-2025. 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.