FDA Medical Device Recalls (openFDA)
Genicon, Inc.: 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
- Recall number
- Z-0094-2021
- Recalling firm
- Genicon, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2020-08-25
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Device Design
- Action
- Genicon issued an updated urgent medical device recall notification on August 29,2020 and initial urgent medical device recall notification was sent on August 24, 2020. The notification states the following action to be taken: To Distributors: Please encourage your customers to complete and return the enclosed response form as soon as possible and return the form by e-mail to customerservice@geniconendo.com. In addition, if you or your customers have any of the affected devices, contact Genicon Customer Service , to coordinate the return of the product associated with this action at no additional cost. Genicon Customer Service Contact Information Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: customerservice@geniconendo.com. To Users: (1)Please confirm whether any of the affected product remains in your inventory by completing the attached Medical Device Recall Response Form and e-mailing it to customerservice@geniconendo.com. (2) Should you find affected product in your inventory, do not use them. (3)Please return affected product to Genicon, Inc. (see below contact details). Genicon Customer Service Manager (contact information below) to coordinate the return at no additional cost. NAME, Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: customerservice@geniconendo.com.
- Quantity
- 10808 units
- 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, SOUTH AFRICA.
- Lot, serial or model codes
- Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C Model # 720-005-001 (BPSI SET 8 VENT PROBE); Lot Numbers: I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3002590791
- Firm city
- Winter Park
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28