Outset Medical Tablo Console Recall: Blood Leak Sensor May Delay Alarm for Hemodialysis
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Outset Medical is recalling Tablo Console models PN-0003000 and PN-0006000 as part of their hemodialysis system. The blood leak sensor may not trigger the alarm at the lowest blood leak rate of 0.35 mL/min, which could delay detection of blood loss under 300ml and cause symptoms like dizziness, fatigue, and shortness of breath in patients. Read more at govinfonow.com/recall/54353-outset-medical-tablo-console-recall-blood-leak-sensor-may-delay.
Source Summary by GovInfoNow · govinfonow.com/recall/54353-outset-medical-tablo-console-recall-blood-leak-sensor-may-delay · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0019-2025
Cite this page
“Outset Medical Tablo Console Recall: Blood Leak Sensor May Delay Alarm for Hemodialysis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54353-outset-medical-tablo-console-recall-blood-leak-sensor-may-delay. Based on FDA recall #Z-0019-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0019-2025%22&limit=1).
Why it’s dangerous
The blood leak sensor in the Tablo Console may show decreased sensitivity at the lowest blood leak rate of 0.35 mL/min. If blood loss occurs under 300ml, the alarm may not trigger in time, potentially causing symptoms like dizziness, fatigue, cramps, headaches, nausea, and shortness of breath.
Who’s affected
Patients using the Tablo Hemodialysis System with the recalled Tablo Console models (PN-0003000 or PN-0006000) are most at risk. Healthcare facilities that use these consoles for hemodialysis treatments may also be affected.
How to tell if you have this one
Check if your Tablo Console has serial numbers listed in the recall: PN-0003000 or PN-0006000. The recall includes specific serial numbers starting with '60' followed by numbers and 'M' or '400' followed by numbers.
- Brand
Outset Medical- Category
Medical device
What to do — step by step
Check Your Console
Look for the serial number on your Tablo Console to see if it matches the list of affected units provided in the recall.
Contact Manufacturer
If your console is affected, contact Outset Medical directly for further instructions.
Where it went and when
Where it was distributed
Distributed in 46 states.
FDA distribution: “US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND. OUS: UAE” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0019-2025 (August 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0019-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.