Z-1485-2024Class I

Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

Name: Z-1485-2024 Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Creator: Outset Medical, Inc.
Published: 2024-03-06
License: https://open.fda.gov/license/

Outset Medical, Inc. / initiated 2024-03-06 / Open, Classified / root cause: design

FDA source

Outset Medical, Inc. began a recall of Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 on 2024-03-06. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1485-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-06
Posted: 2024-04-12
Recalling firm: Outset Medical, Inc.
Product: Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] If you have questions contact the Technical Support team at 844-698-2256
Quantity in commerce: 919
Distribution: US:FL, CA, NM, SC, AZ, TN, NC, TX, IL, MD, IN, DE, AL, MI, AK, KY, LA, ID, OK, IA, VA, GA, MA, NE, KS, WI, PA, OH, WA, MT, RI, MN, MO, AR, NY, CO, WV, SD, OR, UT, WY, DC. OUS: AE
Product codes and lots: UDI-DI: 0850001011112 and 00850001011204. 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1485-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12

Product code KDI

K233335Class IITablo® Hemodialysis SystemOutset Medical, Inc. / cleared 2023-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)