Food, drugs, devices › Outset Medical, Inc.
Device recall: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical, Inc. (San Jose, CA) initiated this device recall on 6 Mar 2024; FDA lists 1 product record under event 94224, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Outset Medical, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Outset Medical, Inc., San Jose, CA.
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."
Distribution
"US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1485-2024 | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 | 919 | Class I | Ongoing | 24 Apr 2024 |
Context
Other enforcement events for Outset Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Aug 2024 | Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi | Device | Class II | 1 |
| 30 Apr 2024 | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 | Device | Class II | 1 |
| 24 Jan 2023 | Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system ( | Device | Class II | 1 |
| 20 Jan 2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | Device | Class II | 1 |
All 5 events for Outset Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.