Tablo Hemodialysis System — Class I medical device recall Z-1485-2024
Ongoing recall by Outset Medical, Inc., reported 2024-04-24, distributed in AK, AL, AR, AZ, CA, CO, DC, DE…. Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, wil
| Recall number | Z-1485-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Outset Medical, Inc., San Jose, CA, United States |
| Recall initiated | 2024-03-06 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Quantity | 919 |
| UPC / GTIN / UDI-DI | 00850001011112, 00850001011204 |
| Serial numbers | 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530 and 475 more |
| Model numbers | PN-0003000, PN-0006000, PN-0007001 |
Product
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Reason for recall
Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
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-1485-2024. 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.