Flowonix Medical recalls

Flowonix Medical has 11 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 7 Jul 2021. 5 are still ongoing. The most frequent reason is device malfunction.

Total recalls11since 2017

Last 12 months0reported

Class I00% of total

Ongoing5latest 7 Jul 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

Why flowonix medical is recalled

Product types

By year

202119%
2020545%
2019436%
201719%

Ongoing flowonix medical recalls

5 active

Reported	Class	Recall	Company	Reason	Where
19 Feb 2020Device	CLASS II	Prometra II Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra II Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	US Clinical Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide

All flowonix medical recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
7 Jul 2021Device	CLASS II	Physician Order Form (PL-15400-00, Nov recalled by Flowonix Medical	Flowonix Medical	Other	Nationwide
19 Feb 2020Device	CLASS II	Prometra II Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra II Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	US Clinical Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
19 Feb 2020Device	CLASS II	Prometra Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	Prometra II Programmable Pump (Clinical) recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	Prometra Programmer (Grand Prime) recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	Prometra Clinician Programmer (Touchscreen) recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide
12 Jun 2019Device	CLASS II	Prometra Programmable Pump recalled by Flowonix Medical	Flowonix Medical	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.