Outset Tablo Console
Medical device recall Z-0813-2022. Published in FDA’s Enforcement Report on Mar 30, 2022.
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 Mar 30, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 47 states named
- 1,123 systems (PN-0003000) and 1,487 (PN-0006000) 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?
Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
1,123 systems (PN-0003000) and 1,487 (PN-0006000), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218; Serial Numbers: 400270 400275 400280 400818 400084 400088 400097 400098 400101 400102 400103 400476 400479 400505 400113 400122 400155 400159 400352 400353 400156 400157…
Every code shown here, 1,994 characters
Model Numbers: PN-0003000 UDI Codes: (01)00850001011112(11)200218; Serial Numbers: 400270 400275 400280 400818 400084 400088 400097 400098 400101 400102 400103 400476 400479 400505 400113 400122 400155 400159 400352 400353 400156 400157 400163 400164 400492 400498 400250 400265 400269 400273 400283 400816 400819 400820 400828 400234 400235 400236 400672 400685 400100 400104 400124 400481 400486 400231 400243 400244 400245 400248 400668 400686 400165 400168 400181 400359 400381 400258 400267 400271 400274 400278 400826 400225 400228 400229 400230 400281 400282 400483 400494 400495 400501 400504 400506 400507 400509 400510 400512 400262 400264 400864 400875 400876 400823 400825 400831 400835 401041 401046 401056 401059 401061 401062 401065 401066 401067 401069 401070 401071 400878 400879 400887 400896 400901 401199 401200 401201 401203 401204 400829 400830 400905 400907 400649 400651 400659 400666 400116 400121 400650 400653 400277 400708 400770 400115 400312 400330 400087 400095 400114 401129 401133 401174 401179 401232 401233 401234 401235 400889 400898 400059 400062 400063 400923 400937 400946 400950 400085 400096 400106 400107 400108 400130 400147 400154 400691 400694 400698 400529 400531 400890 400842 400851 400865 400880 400881 400917 401076 401155 401159 401162 401164 401166 401168 401169 401170 401175 401182 401188 401202 401206 401207 401212 401218 401228 400050 400071 400169 400180 400186 400192 400193 400622 400627 400628 400632 400633 400634 400635 400636 400641 400541 400568 400572 400606 400778 400782 400827 400834 400837 400838 400369 400375 400376 400377 400172 400173 400174 400175 400179 400247 400251 400252 400475 400654 400663 400403 400413 400414 400430 400433 400435 400436 400437 400441 400442 400444 400447 400554 400556 400560 400564 400566 400618 400532 400552 400558 400614 400534 400539 400548 400549 400570 400609 400598 400999 401001 400052 400066 400160 400170 400182 400184 400187 400188 400026 400028 400042 400043 400044 400046 400056…
FDA’s list runs to 19,437 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 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, TN, TX, UT, VA, VT, WA, WV, WI, and WY.
The states and territories these words name
47 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.
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 20, 2022.
- FDA classified it on Mar 21, 2022.
- FDA’s Enforcement Report published it on Mar 30, 2022.
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 19,437 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.