Lower risk Medical device recall · FDA · Published March 6, 2024

Outset Medical Tablo Hemodialysis System Recall: PCBAs in tubing may cause health issues

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1485-2024Medical device Outset Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOutset Medical, Inc.3052 Orchard Dr · San Jose, CA 95134-2011

✎ GovInfoNow plain-language explainer

Outset Medical is recalling certain Tablo Hemodialysis Systems because the tubing may contain PCBAs (non-dioxin-like polychlorinated biphenyl acids) that can cause skin conditions, liver damage, impaired reproduction, and certain cancers. These risks are linked to tubing used less than 336 hours. Read more at govinfonow.com/recall/55959-outset-medical-tablo-hemodialysis-system-recall-pcbas-in-tubing-may.

Source Summary by GovInfoNow · govinfonow.com/recall/55959-outset-medical-tablo-hemodialysis-system-recall-pcbas-in-tubing-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1485-2024

Cite this page

“Outset Medical Tablo Hemodialysis System Recall: PCBAs in tubing may cause health issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55959-outset-medical-tablo-hemodialysis-system-recall-pcbas-in-tubing-may. Based on FDA recall #Z-1485-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1485-2024%22&limit=1).

The FDA announced on March 6, 2024, that Outset Medical, Inc. is recalling Tablo Hemodialysis Systems due to potential exposure to non-dioxin-like polychlorinated biphenyl acids in the tubing. Owners should contact the company for replacement of the affected tubing. GovInfoNow's records show this voluntary Class I recall affects 919 units.

How to tell if you have it

Brand: Outset Medical
Product: Tablo Hemodialysis System
REF: PN-0003000, PN-0006000 and PN-0007001
UDI-DI: 0850001011112 and 00850001011204
Serial Numbers: 400028 through 401122, 600031 through 604080 (including specific M-suffixed codes)
Quantity: 919 units
Distribution: US states including 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

The hazard

The pre and post dialyzer peroxide-cured silicone tubing with less than 336 hours usage may contain non-dioxin-like polychlorinated biphenyl acids that have not been flushed out over time. Exposure to these PCBAs could cause skin conditions, liver damage, impaired reproduction, or the development of certain kinds of cancer in humans.

Context

GovInfoNow's records show Outset Medical, Inc. has 4 other recalls on record since 2022-01-20. Other recent recalls of similar products include Arrow HemoDialysis Kit Recall (2026-04-21) and ReCor Paradise Ultrasound Renal Denervation System Recall (2026-01-29).

How to tell if you have this one

Check the product's part numbers (PN-0003000, PN-0006000, PN-0007001) or serial numbers listed in the recall. The system uses less than 336 hours of operation before the recall applies.

Brand
Outset Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify your Tablo Hemodialysis System's part numbers or serial numbers to see if they match the recalled units.

Where it went and when

Where it was distributed

Distributed in 41 states and D.C..

FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 49 days after the firm started it.

Mar 6, 2024Firm started the recall
Apr 12, 2024FDA classified it Class I
Apr 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Outset Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/55959-outset-medical-tablo-hemodialysis-system-recall-pcbas-in-tubing-may">Outset Medical Tablo Hemodialysis System Recall: PCBAs in tubing may cause health issues (GovInfoNow)</a>

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-1485-2024 (March 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1485-2024 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.