FDA Device recall Z-2724-2026

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401

FDA Device
Class II
ongoing
Published 2026-07-22

On 2026-07-22 the FDA classified a Class II recall of ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401 by Icu Medical, citing in a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2724-2026
Classification	Class II
Status	ongoing
Initiated	2026-06-10
Published	2026-07-22
Last updated	2026-09-13 11:58 UTC
Company	Icu Medical
Distribution	US

Product

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

Reason

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

Identifiers

code_info	UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60… UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60000529, 60000569, 60000580, 60000637, 60000643, 60000647, 60000652, 60000668, 60000670, 60000689, 60000692, 60000695, 60000703, 60000706, 60000710, 60000712, 60000716, 60000718, 60000724, 60000726, 60000754, 60000757, 60000759, 60000765, 60000775, 60000776, 60000781, 60000790, 60000793, 60000801, 60000805, 60000816, 60000830, 60000835, 60000850, 60000857, 60000860, 60000879, 60000883, 60000886, 60000899, 60000903, 60000909, 60000916, 60000917, 60000920, 60000927, 60000933, 60000938, 60000939, 60000942, 60000944, 60000948, 60000951, 60000954, 60000959, 60000960, 60000964, 60000966, 60000967, 60000980, 60000985, 60000987, 60000988, 60000990, 60001007, 60001008, 60001013, 60001028, 60001030, 60001031, 60001034, 60001035, 60001036, 60001037, 60001038, 60001039, 60001040, 60001041, 60001042, 60001043, 60001044, 60001045, 60001047, 60001048, 60001049, 60001050, 60001051, 600

code_info

UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60…

UDI/DI +M335400011, Serial Numbers: 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60000529, 60000569, 60000580, 60000637, 60000643, 60000647, 60000652, 60000668, 60000670, 60000689, 60000692, 60000695, 60000703, 60000706, 60000710, 60000712, 60000716, 60000718, 60000724, 60000726, 60000754, 60000757, 60000759, 60000765, 60000775, 60000776, 60000781, 60000790, 60000793, 60000801, 60000805, 60000816, 60000830, 60000835, 60000850, 60000857, 60000860, 60000879, 60000883, 60000886, 60000899, 60000903, 60000909, 60000916, 60000917, 60000920, 60000927, 60000933, 60000938, 60000939, 60000942, 60000944, 60000948, 60000951, 60000954, 60000959, 60000960, 60000964, 60000966, 60000967, 60000980, 60000985, 60000987, 60000988, 60000990, 60001007, 60001008, 60001013, 60001028, 60001030, 60001031, 60001034, 60001035, 60001036, 60001037, 60001038, 60001039, 60001040, 60001041, 60001042, 60001043, 60001044, 60001045, 60001047, 60001048, 60001049, 60001050, 60001051, 600

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2724-2026%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.