Flowonix Medical Inc recalls
Every recall we track for Flowonix Medical Inc — 12 in all, from 2019–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Flowonix Medical Inc peaked in 2019 (11); 12 since 2017.
All FDA recall records for Flowonix Medical Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 9 | 2 | 0 | 11 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Flowonix Medical Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Flowonix Medical Inc recalls
3 shown- Lower riskMedical device
Flowonix Medical Inc recalls Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable
Flowonix Medical recalls PL-15400-00 Nov 2018 Physician Order Forms used with Prometra pumps due to risk of infection from misinterpreted text about drug reuse.
Flowonix MedicalMay 26, 2021 - Lower riskMedical device
Flowonix Medical Inc recalls Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Flowonix Medical recalls Prometra II 20mL implantable infusion pumps with firmware version 0.26 manufactured from 2012 onward. The pump may not send error codes or emit alarms during valve system issues, potentially leading to undetected problems. Affected units have specific serial numbers listed in the recall.
Flowonix MedicalDec 24, 2019 - Use cautionMedical device
Flowonix Medical Inc recalls Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
Flowonix recalls Prometra Programmable Pump (Cat. No. 11827) for intrathecal infusion due to unexpected shutdowns when Error 115 occurs, caused by software defects in specific programming scenarios.
FlowonixMar 21, 2019
Flowonix Medical Inc recall questions
How many recalls has Flowonix Medical Inc had?
12 recalls from Flowonix Medical Inc are on record with U.S. safety agencies, from 2019–2021.
What is the most recent Flowonix Medical Inc recall?
Flowonix Medical Inc recalls Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable, dated May 26, 2021. Every Flowonix Medical Inc recall is listed on this page, newest first.
What should I do if I have a recalled Flowonix Medical Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Flowonix Medical Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.