FDA Device recall Z-1485-2024

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

FDA Device
Class I
ongoing
Published 2024-04-24

On 2024-04-24 the FDA classified a Class I recall of Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 by Outset Medical, citing 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) polych….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1485-2024
Classification	Class I
Status	ongoing
Initiated	2024-03-06
Published	2024-04-24
Last updated	2026-09-13 11:57 UTC
Company	Outset Medical
Distribution	AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY

Product

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

Reason

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.

Identifiers

code_info	UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400… 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, 60

code_info

UDI-DI: 0850001011112 and 00850001011204. Serial Numbers: 400028, 400093, 400240, 400403, 400407, 400413, 400414, 400…

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, 60

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1485-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.