Food, drugs, devices › Outset Medical, Inc.
Device recall: Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
FDA enforcement event 89616 is a device recall by Outset Medical, Inc. of San Jose, CA, initiated 20 Jan 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 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
"Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0813-2022 | Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000 | 1,123 systems (PN-0003000) and 1,487 (PN-0006000) | Class II | Ongoing | 30 Mar 2022 |
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 |
| 6 Mar 2024 | Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 | Device | Class I | 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 |
All 5 events for Outset Medical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
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.