Flowonix Medical Inc

FDA recalling firm · 4 enforcement events · 13 product records · 2017–2021 · MA, NJ

Flowonix Medical Inc has 4 FDA enforcement events on this register (13 product records) between 2017 and 2021: 4 device; the busiest year was 2019 with 2.

0% of its events are Class I; the most common class is Class II (4). 1 event is listed as ongoing; the recalling firm's address is in MA and NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
26 May 2021	Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable 20mL Pump 00810335020082 13827 Prometra II Programmable 20mLPump 00810335020228 16827 Prometra II…	Device	Class II	1	Terminated
24 Dec 2019	Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082	Device	Class II	6	Ongoing
21 Mar 2019	Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.	Device	Class II	5	Terminated
22 May 2017	PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823,…	Device	Class II	1	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Flowonix Medical Inc by year initiated.

Questions and answers

How many FDA recalls has Flowonix Medical Inc had?

4 enforcement events (13 product records) on this register, 2017–2021: 4 device.

Are any Flowonix Medical Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Flowonix Medical Inc recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.