Outset Medical, Inc. Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Brand
Outset Medical, Inc.
Lot Codes / Batch Numbers
UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530, 400532, 400543, 400546, 400552, 400554, 400556, 400557, 400558, 400560, 400564, 400565, 400566, 400593, 400595, 400598, 400610, 400614, 400615, 400618, 400626, 400657, 400741, 400764, 400775, 400792, 400813, 400837, 400874, 400879, 400894, 400924, 400941, 400942, 400988, 401048, 401120, 401122, 600031, 600059, 600141, 600145, 600146, 600344, 600394, 600396, 600020M, 600021M, 600022M, 600023M, 600025M, 600030M, 600039M, 600095M, 600138M, 600143M, 600181M, 600259M, 600283M, 600285M, 600286M, 600354M, 600355M, 600357M, 600368M, 600373M, 600387M, 600388M, 600392M, 600447M, 600475M, 600481M, 600527M, 600537M, 600556M, 600582M, 600585M, 600587M, 600590M, 600652M, 600692M, 600720M, 600724M, 600727M, 600763M, 600849M, 600966M, 601032M, 601081M, 601095M, 601098M, 601099M, 601107M, 601108M, 601110M, 601114M, 601115M, 601116M, 601117M, 601181M, 601188M, 601301M, 601303M, 601306M, 601308M, 601309M, 601362M, 601376M, 601391M, 601415M, 601417M, 601420M, 601425M, 601428M, 601432M, 601443M, 601450M, 601457M, 601468M, 601469M, 601472M, 601524M, 601527M, 601528M, 601552M, 601554M, 601561M, 601603M, 601666M, 601675M, 601682M, 601699M, 601709M, 601713M, 601721M, 601723M, 601724M, 601726M, 601727M, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 601775M, 601776M, 601778M, 601779M, 601787M, 601789M, 601791M, 601793M, 601799M, 601802M, 601809M, 601816M, 601819M, 601824M, 601825M, 601831M, 601832M, 601833M, 601834M, 601837M, 601840M, 601842M, 601845M, 601847M, 601849M, 601850M, 601851M, 601852M, 601856M, 601857M, 601858M, 601862M, 601863M, 601866M, 601868M, 601875M, 601877M, 601889M, 601896M, 601903M, 601936M, 601944M, 601945M, 601949M, 601950M, 601974M, 602056M, 602083M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 602203M, 602244M, 602248M, 602316M, 602320M, 602323M, 602375M, 602382M, 602384M, 602387M, 602395M, 602400M, 602402M, 602403M, 602430M, 602440M, 602443M, 602452M, 602455M, 602459M, 602461M, 602464M, 602472M, 602477M, 602483M, 602484M, 602490M, 602492M, 602496M, 602498M, 602503M, 602517M, 602522M, 602531M, 602533M, 602535M, 602536M, 602539M, 602545M, 602558M, 602559M, 602566M, 602567M, 602575M, 602578M, 602580M, 602583M, 602585M, 602587M, 602588M, 602589M, 602590M, 602591M, 602593M, 602595M, 602598M, 602599M, 602600M, 602605M, 602607M, 602608M, 602634M, 602635M, 602655M, 602659M, 602660M, 602661M, 602684M, 602698M, 602708M, 602748M, 602752M, 602767M, 602769M, 602770M, 602771M, 602777M, 602779M, 602781M, 602786M, 602791M, 602795M, 602796M, 602799M, 602800M, 602802M, 602804M, 602805M, 602806M, 602810M, 602811M, 602815M, 602816M, 602819M, 602821M, 602823M, 602824M, 602825M, 602826M, 602827M, 602829M, 602830M, 602831M, 602834M, 602835M, 602837M, 602839M, 602840M, 602841M, 602842M, 602844M, 602845M, 602846M, 602849M, 602850M, 602851M, 602852M, 602853M, 602854M, 602855M, 602856M, 602870M, 602881M, 602882M, 602897M, 602903M, 602913M, 602914M, 602916M, 602920M, 602921M, 602922M, 602925M, 602934M, 602935M, 602936M, 602939M, 602940M, 602942M, 602943M, 602944M, 602945M, 602946M, 602947M, 602948M, 602949M, 602950M, 602951M, 602952M, 602953M, 602954M, 602955M, 602956M, 602957M, 602958M, 602959M, 602960M, 602961M, 602962M, 602963M, 602964M, 602965M, 602966M, 602967M, 602968M, 602969M, 602970M, 602971M, 602972M, 602973M, 602975M, 602976M, 602977M, 602978M, 602979M, 602980M, 602981M, 603029M, 603030M, 603031M, 603032M, 603033M, 603034M, 603035M, 603036M, 603037M, 603038M, 603063M, 603064M, 603065M, 603066M, 603073M, 603075M, 603076M, 603078M, 603079M, 603080M, 603081M, 603082M, 603084M, 603085M, 603087M, 603088M, 603093M, 603114M, 603120M, 603124M, 603125M, 603127M, 603128M, 603136M, 603137M, 603138M, 603139M, 603143M, 603145M, 603146M, 603147M, 603148M, 603153M, 603154M, 603155M, 603156M, 603157M, 603158M, 603159M, 603160M, 603161M, 603162M, 603166M, 603167M, 603168M, 603169M, 603170M, 603171M, 603172M, 603174M, 603175M, 603176M, 603178M, 603179M, 603180M, 603181M, 603182M, 603183M, 603184M, 603185M, 603186M, 603190M, 603196M, 603200M, 603202M, 603203M, 603204M, 603205M, 603206M, 603207M, 603212M, 603225M, 603226M, 603227M, 603228M, 603230M, 603231M, 603232M, 603233M, 603234M, 603237M, 603240M, 603241M, 603242M, 603243M, 603244M, 603246M, 603247M, 603248M, 603249M, 603250M, 603253M, 603256M, 603260M, 603261M, 603262M, 603263M, 603264M, 603268M, 603274M, 603275M, 603277M, 603278M, 603281M, 603282M, 603283M, 603284M, 603285M, 603286M, 603290M, 603291M, 603292M, 603293M, 603294M, 603295M, 603296M, 603297M, 603298M, 603299M, 603300M, 603301M, 603302M, 603303M, 603304M, 603305M, 603306M, 603307M, 603308M, 603309M, 603310M, 603311M, 603312M, 603313M, 603314M, 603315M, 603317M, 603318M, 603319M, 603320M, 603321M, 603322M, 603323M, 603324M, 603325M, 603326M, 603327M, 603328M, 603329M, 603334M, 603340M, 603341M, 603342M, 603344M, 603345M, 603346M, 603347M, 603348M, 603349M, 603350M, 603351M, 603353M, 603356M, 603386M, 603402M, 603409M, 603410M, 603413M, 603416M, 603418M, 603419M, 603420M, 603421M, 603422M, 603423M, 603424M, 603425M, 603426M, 603427M, 603431M, 603432M, 603434M, 603437M, 603438M, 603439M, 603440M, 603441M, 603442M, 603447M, 603448M, 603450M, 603453M, 603455M, 603458M, 603463M, 603464M, 603470M, 603472M, 603475M, 603478M, 603481M, 603486M, 603487M, 603488M, 603490M, 603494M, 603496M, 603500M, 603518M, 603519M, 603520M, 603524M, 603526M, 603527M, 603528M, 603529M, 603530M, 603531M, 603533M, 603534M, 603535M, 603536M, 603539M, 603540M, 603541M, 603544M, 603545M, 603546M, 603550M, 603552M, 603554M, 603556M, 603559M, 603560M, 603561M, 603562M, 603564M, 603567M, 603568M, 603569M, 603570M, 603571M, 603572M, 603573M, 603574M, 603578M, 603579M, 603580M, 603581M, 603583M, 603586M, 603587M, 603597M, 603601M, 603602M, 603603M, 603606M, 603607M, 603608M, 603609M, 603610M, 603615M, 603616M, 603617M, 603620M, 603622M, 603625M, 603626M, 603632M, 603633M, 603639M, 603640M, 603641M, 603644M, 603646M, 603647M, 603648M, 603649M, 603650M, 603651M, 603652M, 603653M, 603654M, 603655M, 603658M, 603659M, 603661M, 603663M, 603664M, 603665M, 603667M, 603668M, 603669M, 603670M, 603671M, 603672M, 603673M, 603674M, 603676M, 603677M, 603681M, 603684M, 603686M, 603688M, 603690M, 603692M, 603693M, 603694M, 603695M, 603696M, 603697M, 603699M, 603700M, 603701M, 603702M, 603703M, 603704M, 603705M, 603706M, 603707M, 603708M, 603709M, 603710M, 603711M, 603712M, 603713M, 603714M, 603715M, 603716M, 603717M, 603718M, 603719M, 603721M, 603722M, 603723M, 603724M, 603725M, 603726M, 603727M, 603728M, 603729M, 603730M, 603733M, 603734M, 603738M, 603742M, 603745M, 603746M, 603747M, 603748M, 603750M, 603751M, 603752M, 603754M, 603758M, 603761M, 603762M, 603763M, 603764M, 603767M, 603770M, 603772M, 603775M, 603776M, 603777M, 603778M, 603786M, 603787M, 603791M, 603793M, 603795M, 603796M, 603798M, 603800M, 603802M, 603803M, 603805M, 603806M, 603808M, 603809M, 603810M, 603814M, 603815M, 603816M, 603819M, 603820M, 603821M, 603822M, 603824M, 603825M, 603826M, 603828M, 603830M, 603831M, 603832M, 603833M, 603834M, 603835M, 603837M, 603838M, 603839M, 603840M, 603841M, 603842M, 603843M, 603844M, 603845M, 603846M, 603847M, 603848M, 603849M, 603850M, 603851M, 603852M, 603854M, 603855M, 603856M, 603857M, 603858M, 603859M, 603860M, 603862M, 603863M, 603864M, 603865M, 603866M, 603868M, 603869M, 603877M, 603878M, 603879M, 603881M, 603882M, 603883M, 603884M, 603885M, 603886M, 603887M, 603888M, 603889M, 603890M, 603892M, 603903M, 603905M, 603908M, 603916M, 603918M, 603923M, 603924M, 603926M, 603928M, 603929M, 603934M, 603936M, 603940M, 603941M, 603951M, 603954M, 603959M, 603963M, 603966M, 603969M, 603972M, 603974M, 603976M, 603977M, 603981M, 603984M, 603987M, 603988M, 603989M, 603990M, 603996M, 603999M.604002M, 604004M, 604018M, 604019M, 604020M, 604028M, 604029M, 604037M, 604041M, 604043M, 604046M, 604048M, 604050M, 604051M, 604052M, 604054M, 604055M, 604056M, 604058M, 604062M, 604063M, 604064M, 604067M, 604070M, 604071M, 604074M, 604075M, 604079M, 604080M
Products Sold
UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400416, 400418, 400426, 400430, 400433, 400434, 400435, 400436, 400437, 400441, 400442, 400444, 400447, 400465, 400511, 400513, 400527, 400530, 400532, 400543, 400546, 400552, 400554, 400556, 400557, 400558, 400560, 400564, 400565, 400566, 400593, 400595, 400598, 400610, 400614, 400615, 400618, 400626, 400657, 400741, 400764, 400775, 400792, 400813, 400837, 400874, 400879, 400894, 400924, 400941, 400942, 400988, 401048, 401120, 401122, 600031, 600059, 600141, 600145, 600146, 600344, 600394, 600396, 600020M, 600021M, 600022M, 600023M, 600025M, 600030M, 600039M, 600095M, 600138M, 600143M, 600181M, 600259M, 600283M, 600285M, 600286M, 600354M, 600355M, 600357M, 600368M, 600373M, 600387M, 600388M, 600392M, 600447M, 600475M, 600481M, 600527M, 600537M, 600556M, 600582M, 600585M, 600587M, 600590M, 600652M, 600692M, 600720M, 600724M, 600727M, 600763M, 600849M, 600966M, 601032M, 601081M, 601095M, 601098M, 601099M, 601107M, 601108M, 601110M, 601114M, 601115M, 601116M, 601117M, 601181M, 601188M, 601301M, 601303M, 601306M, 601308M, 601309M, 601362M, 601376M, 601391M, 601415M, 601417M, 601420M, 601425M, 601428M, 601432M, 601443M, 601450M, 601457M, 601468M, 601469M, 601472M, 601524M, 601527M, 601528M, 601552M, 601554M, 601561M, 601603M, 601666M, 601675M, 601682M, 601699M, 601709M, 601713M, 601721M, 601723M, 601724M, 601726M, 601727M, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 601775M, 601776M, 601778M, 601779M, 601787M, 601789M, 601791M, 601793M, 601799M, 601802M, 601809M, 601816M, 601819M, 601824M, 601825M, 601831M, 601832M, 601833M, 601834M, 601837M, 601840M, 601842M, 601845M, 601847M, 601849M, 601850M, 601851M, 601852M, 601856M, 601857M, 601858M, 601862M, 601863M, 601866M, 601868M, 601875M, 601877M, 601889M, 601896M, 601903M, 601936M, 601944M, 601945M, 601949M, 601950M, 601974M, 602056M, 602083M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 602203M, 602244M, 602248M, 602316M, 602320M, 602323M, 602375M, 602382M, 602384M, 602387M, 602395M, 602400M, 602402M, 602403M, 602430M, 602440M, 602443M, 602452M, 602455M, 602459M, 602461M, 602464M, 602472M, 602477M, 602483M, 602484M, 602490M, 602492M, 602496M, 602498M, 602503M, 602517M, 602522M, 602531M, 602533M, 602535M, 602536M, 602539M, 602545M, 602558M, 602559M, 602566M, 602567M, 602575M, 602578M, 602580M, 602583M, 602585M, 602587M, 602588M, 602589M, 602590M, 602591M, 602593M, 602595M, 602598M, 602599M, 602600M, 602605M, 602607M, 602608M, 602634M, 602635M, 602655M, 602659M, 602660M, 602661M, 602684M, 602698M, 602708M, 602748M, 602752M, 602767M, 602769M, 602770M, 602771M, 602777M, 602779M, 602781M, 602786M, 602791M, 602795M, 602796M, 602799M, 602800M, 602802M, 602804M, 602805M, 602806M, 602810M, 602811M, 602815M, 602816M, 602819M, 602821M, 602823M, 602824M, 602825M, 602826M, 602827M, 602829M, 602830M, 602831M, 602834M, 602835M, 602837M, 602839M, 602840M, 602841M, 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Outset Medical, Inc. is recalling Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 due to Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 3/6/24, correction notices were mailed to customers who were informed that the firm has qualified silicone tubing manufactured with a platinum initiator (platinum-cured) replacement to eliminate the presence of NDL-PCBAs. Field Service Engineers service starting in March 2024. Customers were asked to do the following: 1) Disseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred. 2) Identify and notify your home patients that were shipped or may have been shipped affected product. 3) Affected devices can be used until serviced. If you have new affected hemodialysis system(s), consider using other alternative machines, if any are available. If you only have new hemodialysis systems available to use, continue to use them so that your patients have access to dialysis treatment. Devices starting with serial number 604572M were manufactured with platinum-cured tubing and are not affected. 4) Complete and return the acknowledgement and receipt form via email to FieldActionAdvisory@OutsetMedical.com If you have questions contact the Technical Support team at 844-698-2256
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, DC
Page updated: Jan 10, 2026