Outset Tablo
Medical device recall Z-1351-2023. Published in FDA’s Enforcement Report on Apr 19, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 19, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 33 states named
- 374 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
374 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: PN-0006000 PN-0007001 UDI-DI Code: 00850001011204 Serial Numbers for PN-00060000 600102M 600185M 600226M 600229M 600241M 600251M 600307M 600383M 600430M 600554M 600668M 600684M 600741M 600742M 600747M 600757M 600774M 600815M…
Every code shown here, 2,000 characters
Model Numbers: PN-0006000 PN-0007001 UDI-DI Code: 00850001011204 Serial Numbers for PN-00060000 600102M 600185M 600226M 600229M 600241M 600251M 600307M 600383M 600430M 600554M 600668M 600684M 600741M 600742M 600747M 600757M 600774M 600815M 600816M 600817M 600826M 600828M 600829M 600856M 600858M 600867M 600869M 600875M 600899M 600904M 600925M 600932M 600947M 600954M 600964M 600974M 600981M 600983M 600987M 600988M 601051M 601052M 601053M 601055M 601061M 601069M 601071M 601073M 601074M 601078M 601079M 601083M 601087M 601091M 601092M 601093M 601094M 601097M 601101M 601103M 601104M 601106M 601111M 601112M 601113M 601118M 601119M 601120M 601124M 601125M 601126M 601127M 601128M 601129M 601130M 601131M 601132M 601135M 601136M 601137M 601138M 601139M 601140M 601141M 601142M 601143M 601144M 601145M 601146M 601147M 601148M 601149M 601150M 601151M 601152M 601155M 601156M 601157M 601158M 601159M 601160M 601161M 601162M 601164M 601166M 601167M 601169M 601171M 601172M 601173M 601174M 601175M 601176M 601177M 601178M 601179M 601180M 601182M 601185M 601186M 601187M 601190M 601192M 601193M 601194M 601195M 601196M 601197M 601198M 601199M 601200M 601201M 601202M 601203M 601204M 601206M 601207M 601209M 601210M 601211M 601212M 601213M 601214M 601215M 601216M 601217M 601218M 601219M 601221M 601222M 601223M 601224M 601226M 601227M 601230M 601231M 601232M 601233M 601234M 601235M 601236M 601237M 601238M 601241M 601243M 601245M 601246M 601247M 601250M 601251M 601252M 601254M 601255M 601256M 601257M 601258M 601259M 601260M 601265M 601266M 601267M 601268M 601269M 601270M 601271M 601272M 601273M 601274M 601276M 601277M 601280M 601281M 601282M 601284M 601285M 601286M 601287M 601288M 601290M 601291M 601292M 601293M 601294M 601296M 601298M 601299M 601300M 601304M 601307M 601310M 601313M 601320M 601322M 601323M 601325M 601327M 601329M 601330M 601331M 601332M 601333M 601334M 601335M 601348M 601349M 601352M 601356M 601358M 601359M 601362M 601366M 601367M 601375M 601376M 601382M 601386M 601387M 601391M…
FDA’s list runs to 3,118 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.
The states and territories these words name
33 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- California
- Colorado
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 24, 2023.
- FDA classified it on Apr 7, 2023.
- FDA’s Enforcement Report published it on Apr 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Outset Medical, Inc., of San Jose, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,118 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.