PlainRecalls

Flowonix Medical Inc

Compiled from official public sources by the publisher.

13 recalls on record · Latest: Jul 7, 2021

Subscribe to new Flowonix Medical Inc recalls (RSS)

Agency notice ledger

Federal filing book Flowonix Medical Inc LIGHT-BOOK · SINGLE-AGENCY

#1,171 of 14,151 · 13 notices · 0.012% archive

  • BOOK 13 notices
  • RANK #1,171 of 14,151
  • SHARE 0.012% archive
  • AGENCY FDA Devices (13)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jul 7, 2021
  • PHOTO Access Scientific LLC

Nearest notice-volume peer: Access Scientific LLC (0 notice gap)

Flowonix Medical Inc accounts for about 0.012% of the 104,423-notice archive on 13 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Flowonix Medical Inc compares to 14,151 recalling firms

Flowonix Medical Inc ranks 1,171st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Flowonix Medical Inc vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

13 1171st of 14151 higher than 12,927 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-15

Flowonix Medical Inc in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Flowonix Medical Inc holds about 0.012% of archive notices alongside 13 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jul 7, 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 Programmable 40mLPump 00810335020242
FDA Devices Moderate Feb 19, 2020

Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
FDA Devices Moderate Feb 19, 2020

Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
FDA Devices Moderate Feb 19, 2020

US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
FDA Devices Moderate Feb 19, 2020

Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
FDA Devices Moderate Feb 19, 2020

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
FDA Devices Moderate Feb 19, 2020

Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
FDA Devices Moderate Jun 12, 2019

Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
FDA Devices Moderate Jun 12, 2019

Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
FDA Devices Moderate Jun 12, 2019

Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
FDA Devices Moderate Jun 12, 2019

Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
FDA Devices Moderate Jun 12, 2019

Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
FDA Devices Moderate Jul 26, 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, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Pat

Flowonix Medical Inc holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (13 here — thin-book).

Access Scientific LLC 13 Acclarent, Inc. 13 Advanced Bionics, LLC 13 Aequita Pharmacy 13 Alden Optical 13

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Access Scientific LLC 13 Acclarent, Inc. 13 Advanced Bionics, LLC 13 Aequita Pharmacy 13

Frequently Asked Questions

How many federal recall notices name Flowonix Medical Inc? ▼
PlainRecalls indexes 13 distinct federal recall events naming Flowonix Medical Inc, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Flowonix Medical Inc sit among other recalling firms? ▼
Flowonix Medical Inc ranks #1,171 of 14,151 by distinct recall-event count among 14,151 firms in this archive (91st percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Flowonix Medical Inc's notices? ▼
FDA Devices accounts for 13 of this firm's 13 indexed notices.
What product category dominates Flowonix Medical Inc's filing book? ▼
Filings for Flowonix Medical Inc span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Flowonix Medical Inc: 13 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Flowonix Medical Inc; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026