Outset Medical, Inc. recalls
Every recall we track for Outset Medical, Inc. — 5 in all, from 2022–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Outset Medical, Inc. peaked in 2024 (3); 5 since 2017.
All FDA recall records for Outset Medical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 2 | 1 | 0 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Outset Medical, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Outset Medical, Inc. recalls
5 shown- Use cautionMedical device
Outset Medical, Inc. recalls Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is
Outset Medical recalls Tablo Console models PN-0003000 and PN-0006000 due to blood leak sensor potentially delaying alarm for hemodialysis patients, risking hypotension and other symptoms. Affected units have specific serial numbers listed in the recall.
Outset MedicalAug 1, 2024 - Use cautionMedical device
Outset Medical, Inc. recalls TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot),
Outset Medical recalls TabloCart with Prefiltration Drawer (PN-0006813) with specific power cords due to potential electrical hazards from damaged connectors that could cause heat, sparks, or fire. Affected units may need replacement.
Outset MedicalApr 30, 2024 - Lower riskMedical device
Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Outset Medical recalls Tablo Hemodialysis Systems with specific part numbers due to potential PCBAs in tubing that could cause skin conditions, liver damage, and cancer risks. Affected units have serial numbers listed in the recall.
Outset MedicalMar 6, 2024 - Lower riskMedical device
Outset Medical, Inc. recalls Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system
Outset Medical recalls Tablo hemodialysis systems (model PN-0006000, PN-0007001) due to high conductivity dialysate alarms from software changes. Affected units have specific serial numbers.
OutsetJan 24, 2023 - Lower riskMedical device
Outset Medical, Inc. recalls Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
Outset Medical recalls two models of hemodialysis consoles (PN-0003000 and PN-0006000) due to a component that may cause heat-related damage. Affected units have specific serial numbers and UDI codes listed in the recall notice.
Outset MedicalJan 20, 2022
Outset Medical, Inc. recall questions
How many recalls has Outset Medical, Inc. had?
5 recalls from Outset Medical, Inc. are on record with U.S. safety agencies, from 2022–2024.
What is the most recent Outset Medical, Inc. recall?
Outset Medical, Inc. recalls Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is, dated Aug 1, 2024. Every Outset Medical, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Outset Medical, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Outset Medical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.