Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemo...
FDA Device Recall #Z-0019-2025 — Class II — August 1, 2024
Recall Summary
| Recall Number | Z-0019-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 1, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Outset Medical, Inc. |
| Location | San Jose, CA |
| Product Type | Devices |
| Quantity | 2,422 |
Product Description
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 for Recall
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.
Distribution Pattern
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
Lot / Code Information
UDI-DI: 00850001011112, 00850001011204. 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600681M, 600682M, 600683M, 601153M, 601333M, 601334M, 601335M, 601336M, 602037M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 601191M, 601241M, 601255M, 601268M, 401141, 600376M, 600391M, 600670M, 600845M, 600846M, 600758M, 601490M, 600133M, 600153M, 600630M, 600151M, 600627M, 601758M, 601769M, 602078M, 600706M, 600708M, 600709M, 600783M, 601575M, 601583M, 601888M, 601894M, 601904M, 601911M, 600115M, 600118M, 600878M, 600883M, 601781M, 601785M, 601807M, 601839M, 602480M, 602487M, 602497M, 602501M, 602505M, 602491M, 602495M, 602502M, 602506M, 600082M, 600900M, 600608M, 602280M, 602282M, 602285M, 602286M, 600244, 601794M, 601795M, 602341M, 602347M, 602350M, 602453M, 602457M, 600842M, 600844M, 602550M, 602551M, 602552M, 602555M, 602568M, 602645M, 602658M, 602669M, 602674M, 602676M, 602678M, 602653M, 602666M, 602554M, 602565M, 602205M, 602203M, 602196M, 602200M, 602204M, 600685M, 600692M, 600711M, 600720M, 600722M, 601161M, 601623M, 601287M, 601288M, 601289M, 600748M, 600751M, 601375M, 601167M, 601304M, 602488M, 602489M, 601984M, 601985M, 601986M, 602588M, 602593M, 602517M, 602589M, 602591M, 601634M, 602208M, 601275M, 601365M, 601382M, 601519M, 601635M, 602079M, 601387M, 601147M, 601541M, 602587M, 602048M, 602085M, 600984M, 602246M, 601046M, 602042M, 602044M, 602090M, 602158M, 602621M, 602598M, 602258M, 600481M, 601472M, 602536M, 601327M, 601483M, 602223M, 602484M, 601343M, 601618M, 601682M, 602662M, 601127M, 601179M, 601627M, 602235M, 602339M, 600324, 600397M, 600464M, 600544M, 600972M, 600973M, 600978M, 601029M, 601154M, 601638M, 601803M, 602061M, 602066M, 602074M, 602152M, 602176M, 602460M, 600463M, 601002M, 601568M, 601725M, 602091M, 602054M, 601087M, 602791M, 601431M, 601630M, 602143M, 602178M, 600607M, 601548M, 601556M, 602151M, 602154M, 602179M, 602233M, 602240M, 602126M, 601421M, 602409M, 602193M, 601143M, 601481M, 600346M, 600995M, 601144M, 601158M, 601160M, 602039M, 602046M, 602047M, 602051M, 601711M, 601222M, 601254M, 602180M, 601661M, 602498M, 602041M, 602055M, 601135M, 602034M, 602057M, 602440M, 600814M, 600862M, 602109M, 602595M, 600338M, 602473M, 601469M, 602269M, 601277M, 602174M, 600348M, 600365M, 600428M, 600455M, 600993M, 601212M, 602059M, 602086M, 602140M, 602149M, 602469M, 602478M, 602482M, 602077M, 601656M, 602100M, 601675M, 602522M, 601654M, 602110M, 602395M, 602455M, 602443M, 601559M, 602770M, 601467M, 600364M, 602600M, 602137M, 602367M, 600396M, 600426M, 601238M, 601264M, 602144M, 602153M, 602249M, 602259M, 601607M, 602585M, 602458M, 601751M, 602095M, 602206M, 600514M, 600494M, 600500M, 600556M, 602459M, 600271M, 600516M, 600613M, 601140M, 601142M, 601292M, 601322M, 602094M, 602096M, 602104M, 600269M, 600270M, 601136M, 602062M, 601663M, 600482M, 602064M, 602171M, 600992M, 602076M, 602463M, 601757M, 600480M, 601560M, 601610M, 602145M, 601468M, 601629M, 600457M, 600996M, 601173M, 601180M, 601597M, 601631M, 601632M, 601669M, 602260M, 602372M, 601603M, 600474M, 601155M, 600486M, 601636M, 602049M, 602052M, 602058M, 602084M, 602239M, 602045M, 602256M, 601666M, 602227M, 602093M, 602155M, 602254M, 601443M, 601473M, 600551M, 600632M, 600668M, 600439M, 601362M, 602036M, 602043M, 602050M, 602119M, 600491M, 601150M, 602081M, 601341M, 601633M, 601415M, 602138M, 600622M, 602289M, 602780M, 601813M, 601543M, 602607M, 601366M, 601376M, 602586M, 602583M, 600461M, 602273M, 600447M, 600467M, 602628M, 602483M, 602545M, 602127M, 602107M, 601342M, 602599M, 601344M, 602177M, 602461M, 600859M, 400424, 400425, 401243, 400995, 602265M, 602268M, 602270M, 601521M, 601522M, 401262, 602162M, 602181M, 602266M, 602378M, 602380M, 602215M, 602228M, 602263M, 602116M, 602117M, 600865M, 600873M, 600889M, 600716M, 600717M, 600719M, 600625M, 600628M, 602601M, 601471M, 601474M, 601475M, 601478M, 601391M, 601392M, 602794M, 601428M, 602655M, 600501M, 600982M, 601352M, 602302M, 602366M, 600583M, 600983M, 602313M, 602375M, 601411M, 601420M, 602752M, 602661M, 601410M, 602646M, 602467M, 602602M, 600667M, 601445M, 601446M, 601463M, 601476M, 601194M, 601197M, 601236M, 601237M, 601252M, 601302M, 601311M, 600108M, 600109M, 600119M, 600123M, 600629M, 600633M, 600634M, 600638M, 600665M, 601229M, 601316M, 601372M, 601412M, 601439M, 601448M, 601451M, 601458M, 601460M, 600871M, 600879M, 601766M, 601768M, 601770M, 600405M, 600407M, 600415M, 600420M, 600424M, 600932M, 600933M, 600938M, 600945M, 600735M, 600755M, 601061M, 601062M, 601184M, 601188M, 601189M, 602004M, 602005M, 602615M
Other Recalls from Outset Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2150-2024 | Class II | TabloCart with Prefiltration Drawer PN-0006813,... | Apr 30, 2024 |
| Z-1485-2024 | Class I | Tablo Hemodialysis System, REF: PN-0003000, PN-... | Mar 6, 2024 |
| Z-1351-2023 | Class II | Outset Tablo Model Numbers (REF): PN-000600... | Jan 24, 2023 |
| Z-0813-2022 | Class II | Outset Tablo Console Model Number: PN-000300... | Jan 20, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.