UnratedMedical device recall · FDA · Published August 25, 2020
Genicon Aquas PowerFlow Tube Set Recall: FDA Clearance Issue
Genicon recalls Aquas PowerFlow Tube Sets due to lack of FDA premarket clearance. These surgical irrigation devices may not be safe for use during laparoscopic procedures.
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
“Genicon Aquas PowerFlow Tube Set Recall: FDA Clearance Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64431-genicon-aquas-powerflow-tube-set-recall-fda-clearance-issue. Based on FDA recall #Z-0094-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0094-2021%22&limit=1).
The FDA announced on Aug. 25, 2020, that Genicon, Inc. is recalling Aquas PowerFlow Tube Sets because the device lacks required premarket clearance. The hazard involves a motor-driven impeller pump powered by a 9V battery inside the hand-piece.
How to tell if you have it
Brand: Genicon
Product: Aquas PowerFlow Tube Set
Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C
The FDA stated the product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance and lacks a 510(k).
Context
GovInfoNow's records show Genicon, Inc. has had four other recalls since July 19, 2017. Other recent recalls of similar products include Glypto Cryo Machine Recall (Aug. 24, 2026), Medline PICC Tray DYNJ41648A Recall (Feb. 25, 2026), and Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK recall (Feb. 25, 2026).
How to tell if you have this one
Check for model numbers 720-005-000 (BPSI SET WITH NO PROBE) or 720-005-001 (BPSI SET 8 VENT PROBE). The lot numbers listed in the recall include I9214-C through I9365-D.
Brand
Genicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the model number and lot number on your Aquas PowerFlow Tube Set to see if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Iowa, Massachusetts, Michigan, Missouri, North Carolina, Ohio, Tennessee, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0094-2021 (August 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0094-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.