PlainRecordsBrand recall history
Flowonix Medical recalls
Every FDA recall record we found for Flowonix Medical, newest first. Updated Oct. 11, 2026.
4
4 recalls since 2017. The most recent was on July 7, 2021.
- Last 12 months
- 0
- Most recent
- 2021-07
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2017–202617181920212223242526
Class I (FDA, most serious)Other recalls
All recalls
4- July 7, 2021Physician Order Form (PL-15400-00… Class IIPhysician Order Form (PL-15400-00 Nov 2018) distributed is discontinued due to the text 'Refill the pump and program refill with the same medication…
- Feb. 19, 2020Prometra Programmable 20mL Pump… and 5 more products Class IIA pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer…
- June 12, 2019Prometra Clinician Programmer (Touchscreen) Software version 2.00.29… and 4 more products Class IIThe pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error…
- July 26, 2017PROMETRA II Programmable Infusion Pump… Class IIFlowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during…
No recalls match.
How we match: a recall is listed here when the agency names Flowonix Medical as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.