Recall archive / FDA device enforcement

Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is i... — FDA record Z-0019-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Reason: 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.
Classification: Class II
Recalling firm: Outset Medical, Inc.
Quantity: 2,422
Agency-reported status: Ongoing
Source record identifier: Z-0019-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	UDI-DI: 00850001011112, 00850001011204. Serial Numbers: 400405, 602382M, 602384M, 602387M, 602400M, 602402M, 601124M, 601156M, 601102M, 601265M, 400109, 602248M, 602659M, 602670M, 602767M, 602769M, 602771M, 601356M, 602421M, 602403M, 400394, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 600599M, 600614M, 600615M, 600620M, 600631M, 600641M, 600646M, 600648M, 600654M, 600659M, 601337M, 601357M, 601360M, 601361M, 601364M, 601368M, 601384M, 601395M, 601396M, 601422M, 601727M, 602748M, 600189, 601515M, 601513M, 601514M, 601517M, 601518M, 601838M, 601864M, 601870M, 601915M, 601924M, 601823M, 601854M, 601861M, 601887M, 601901M, 601908M, 601923M, 601903M, 601936M, 601945M, 601974M, 601799M, 600484M, 601876M, 601886M, 601938M, 601941M, 600488M, 601129M, 601146M, 601270M, 601298M, 601797M, 601805M, 601812M, 601814M, 601821M, 601855M, 601890M, 601897M, 601932M, 601934M, 600563M, 600569M, 600572M, 600574M, 601952M, 601954M, 601878M, 601899M, 601935M, 601942M, 601943M, 601947M, 601800M, 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Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI: 00850001011112, 00850001011204. Serial Numbers: 400405, 602382M, 602384M, 602387M, 602400M, 602402M, 601124M, 601156M, 601102M, 601265M, 400109, 602248M, 602659M, 602670M, 602767M, 602769M, 602771M, 601356M, 602421M, 602403M, 400394, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 600599M, 600614M, 600615M, 600620M, 600631M, 600641M, 600646M, 600648M, 600654M, 600659M, 601337M, 601357M, 601360M, 601361M, 601364M, 601368M, 601384M, 601395M, 601396M, 601422M, 601727M, 602748M, 600189, 601515M, 601513M, 601514M, 601517M, 601518M, 601838M, 601864M, 601870M, 601915M, 601924M, 601823M, 601854M, 601861M, 601887M, 601901M, 601908M, 601923M, 601903M, 601936M, 601945M, 601974M, 601799M, 600484M, 601876M, 601886M, 601938M, 601941M, 600488M, 601129M, 601146M, 601270M, 601298M, 601797M, 601805M, 601812M, 601814M, 601821M, 601855M, 601890M, 601897M, 601932M, 601934M, 600563M, 600569M, 600572M, 600574M, 601952M, 601954M, 601878M, 601899M, 601935M, 601942M, 601943M, 601947M, 601800M, 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600107M, 600198M, 602148M, 600374M, 600377M, 600451M, 600452M, 600784M, 601126M, 601195M, 601201M, 601325M, 601174M, 601177M, 602150M, 601070M, 601072M, 601073M, 601564M, 601565M, 601569M, 601571M, 601578M, 601579M, 601680M, 601685M, 601687M, 602225M, 602063M, 602065M, 602067M, 602069M, 601499M, 601501M, 601611M, 601612M, 601614M, 602679M, 602681M, 602683M, 601581M, 601588M, 601590M, 601593M, 601595M, 601599M, 602214M, 602216M, 602182M, 602183M, 602187M, 601059M, 601079M, 601092M, 601096M, 601101M, 600440M, 602128M, 602291M, 602292M, 602293M, 602294M, 602295M, 602357M, 602358M, 602462M, 602526M, 602632M, 601027M, 601045M, 601055M, 601065M, 601067M, 602146M, 602147M, 601545M, 601546M, 601549M, 600542M, 602560M, 602562M, 602569M, 601703M, 601705M, 601708M, 601710M, 602352M, 602356M, 602359M, 602362M, 602368M, 600617M, 600621M, 601028M, 601042M, 601088M, 602296M, 602297M, 602298M, 602299M, 601526M, 601531M, 601054M, 601172M, 602213M, 600438M, 600448M, 600449M, 600549M, 601715M, 601718M, 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600188M, 600194M, 600196M, 600197M, 600200M, 600649M, 601465M, 601480M, 600555M, 600558M, 600559M, 600560M, 600562M, 600912M, 600913M, 600914M, 600915M, 600230, 600046M, 600493M, 600509M, 600299M, 600307M, 600325M, 600326M, 600328M, 600990M, 601492M, 601500M, 601503M, 601504M, 600780M, 600820M, 600821M, 600847M, 600850M, 600854M, 600866M, 602452M, 602492M, 602531M, 602533M, 602799M, 600575M, 600579M, 600580M, 600694M, 600700M, 600730M, 600962M, 601014M, 600673M, 600677M, 600680M, 600693M, 600741M, 601004M, 601012M, 600731M, 600887M, 600917M, 600918M, 600919M, 600175M, 600096M, 600301M, 600987M, 601646M, 601647M, 601649M, 601659M, 401118, 600798M, 600838M, 600840M, 600841M, 600331M, 600332M, 400222, 400227, 600294M, 601251M, 601260M, 601262M, 600306M, 600315M, 600317M, 600981M, 600985M, 601290M, 601291M, 601299M, 601404M, 601449M, 600413M, 600561M, 600565M, 600924M, 600416M, 600429M, 600459M, 600573M, 600576M, 600939M, 600281, 600391, 600012M, 600961M, 600233, 600392M, 400463, 601929M, 601937M, 601939M, 600181M, 600283M, 600286M, 601017M, 601589M, 602288M, 602290M, 602098M, 602099M, 602101M, 600357M, 600652M, 400487, 600507M, 600508M, 600512M, 600513M, 600521M, 600522M, 600524M, 600525M, 601374M, 601378M, 601379M, 601380M, 601381M, 601373M, 601388M, 601390M, 601394M, 601399M, 600528M, 600532M, 600964M, 601743M, 601745M, 601754M, 601765M, 601773M, 602494M, 602499M, 401082, 600922M, 600923M, 600024M, 600026M, 600031M, 600040M, 600042M, 401194, 601122M, 601271M, 600610M, 600870M, 600872M, 600903M, 600908M, 600911M, 602014M, 602015M, 602016M, 602017M, 600598M, 600602M, 600603M, 600802M, 600803M, 600804M, 600805M, 601977M, 600195M, 601121M, 400141, 600446M, 600458M, 600408M, 600410M, 600321M, 600892M, 600898M, 601637M, 602838M, 601849M, 601852M, 600707M, 600713M, 601850M, 601851M, 601856M, 600206, 600252M, 600257M, 600258M, 600686M, 600793M, 600890M, 600404M, 600418M, 600430M, 600975M, 600979M, 600991M, 600100M, 601048M, 601112M, 601113M, 600742M, 601053M, 601056M, 601060M, 601100M, 601665M, 400849, 601990M, 601993M, 600204M, 600894M, 601280M, 601323M, 601339M, 602392M, 601193M, 602097M, 602241M, 602394M, 601185M, 601587M, 600734M, 600752M, 601162M, 601525M, 600736M, 602136M, 600800M, 601605M, 602088M, 602383M, 400058, 400082, 400317, 600237M, 600403M, 601914M, 601917M, 601918M, 601919M, 601920M, 601921M, 601922M, 601925M, 601926M, 600032M, 600564M, 600570M, 600329, 600880M, 600901M, 601118M, 601119M, 600309M, 600310M, 600312M, 600316M, 600318M, 600113M, 600313M, 600891M, 601095M, 601098M, 601099M, 601107M, 601108M, 600298M, 600304M, 600327M, 601080M, 601084M, 601086M, 601089M, 601091M, 400048, 600394M, 600395M, 601071M, 601078M, 601246M, 601269M, 601297M, 602348M, 602385M, 602388M, 602401M, 602406M, 602408M, 602410M, 602412M, 602414M, 602415M, 602509M, 602510M, 602527M, 602528M, 602534M, 600070M, 600074M, 600076M, 600077M, 600083M, 600085M, 600893M, 600965M, 600969M, 600971M, 602165M, 602170M, 602186M, 602189M, 602190M, 601542M, 601592M, 601204M, 601219M, 601232M, 601233M, 600876M, 600877M, 600595M, 600596M, 600612M, 601782M, 601784M, 601788M, 601792M, 602790M, 601025M, 601678M, 601683M, 601684M, 601686M, 601242M, 601245M, 601248M, 601249M, 601263M, 400440, 600149M, 600159M, 600697M, 601487M, 601488M, 600192M, 600427M, 600951M, 600166M, 600333M, 600953M, 600134M, 600145M, 600150M, 602446M, 600203M, 600433M, 600068M, 602512M, 602516M, 602518M, 602519M, 602523M, 602524M, 602529M, 602530M, 602541M, 602563M, 600714M, 600756M, 600762M, 600765M, 600690M, 602578M, 602698M, 602580M, 602635M, 602634M, 602684M, 602103M, 602106M, 602102M, 602597M, 602614M, 602691M, 602692M, 602695M, 602704M, 602706M, 602711M, 602712M, 602713M, 601740M, 601741M, 601742M, 600485M, 600643M, 600084, 602449M, 602450M, 602504M, 602546M, 602577M, 601274M, 601281M, 601286M, 600293M, 600295M, 600320M, 600322M, 600323M, 602633M, 602636M, 602640M, 602641M, 602642M, 602644M, 601034M, 601038M, 601981M, 601983M, 602564M, 602604M, 602639M, 602652M, 602657M, 602667M, 602671M, 602673M, 602535M, 602539M, 600869M, 600907M, 602581M, 602592M, 602606M, 602611M, 602393M, 602389M, 602396M, 602596M, 601244M, 601283M, 601324M, 601780M, 600653M, 600655M, 600656M, 600657M, 600661M, 600021M, 600025M, 600023M, 600022M, 601340M, 601351M, 601355M, 601397M, 601452M, 601453M, 601454M, 600434M, 600519M, 600520M, 600523M, 600540M, 600936M, 600947M, 601707M, 400288, 600526M, 601464M, 601470M, 601477M, 601609M, 601619M, 601621M, 600592M, 600593M, 600594M, 600604M, 600030M, 600039M, 600902M, 600904M, 600591M, 601047M, 601128M, 601762M, 601763M, 600600M, 601024M, 601044M, 601755M, 601760M, 601761M, 602668M, 600060M, 600533M, 600534M, 602032M, 602033M, 601691M, 601692M, 601693M, 601694M, 602575M, 602576M, 600454M, 601137M, 601328M, 601329M, 601330M, 601331M, 601332M, 600178M, 600431M, 600874M, 600199, 600465M, 600478M, 601419M, 602087M, 602089M, 601524M, 601527M, 601528M, 602275M, 602277M, 602278M, 602194M, 602195M, 602197M, 602198M, 601537M, 601538M, 601540M, 602080M, 602139M, 602157M, 601063M, 601064M, 601066M, 602584M, 602603M, 602619M, 602630M, 600796M, 601441M, 601447M, 601479M, 601485M, 601497M, 602325M, 602327M, 602329M, 602330M, 602336M, 602337M, 601493M, 601520M, 601523M, 600605M, 600626M, 600639M, 601673M, 601674M, 601746M, 602083M, 401144, 600132M, 600342M, 600343M, 600241M, 600242M, 600243M, 602131M, 600253M, 600197, 600268M, 600273M, 600245M, 600247M, 600250M, 600266M, 600351M, 600265M, 600356M, 600358M, 600341M, 600347M, 600349M, 600214M, 600290M, 601000M, 601003M, 600035M, 600041M, 600977M, 600980M, 601808M, 601828M, 601829M, 601830M, 601843M, 600825M, 601958M, 601804M, 601956M, 601960M, 601973M, 601979M, 601907M, 601909M, 601910M, 601912M, 601913M, 601916M, 601720M, 602118M, 602121M, 602124M, 600636M, 600637M, 600642M, 600650M, 601859M, 601867M, 600645M, 600647M, 600658M, 600660M, 600664M, 601239M, 601860M, 601865M, 601965M, 601966M, 601967M, 601968M, 601969M, 602649M, 602650M, 602363M, 602376M, 602377M, 602379M, 602390...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Oct 9, 2024
Recall initiation date: Aug 1, 2024
Center classification date: Oct 3, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records