The Recall Desk
HighFDA (Devices)·Z-0094-2021·Announced 2020-10-21

Genicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance

Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or injury are assigned a score of 3 (High), representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set. This medical device is used to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke. The recall affects specific model numbers 720-005-000 and 720-005-001 across various lot numbers.

The recall was initiated because the product design, which incorporates a motor-driven impeller pump powered by one 9V alkaline battery inside the hand-piece, did not receive proper premarket clearance from the US Food and Drug Administration and lacks a 510(k). The agency classification for this recall is Class II.

The affected units were distributed worldwide, including nationwide distribution in the United States and in countries such as Ecuador, Hong Kong, Qatar, Saudi Arabia, UAE (Dubai), Jordan, Kuwait, and South Africa. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
Manufacturer
Genicon, Inc.
Category
Medical Device — Surgical Irrigation
Hazard
Affected units
10,808

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model # 720-005-000 (BPSI SET WITH NO PROBE)
  • Lot # I9214-C Model # 720-005-001 (BPSI SET 8 VENT PROBE)

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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