Aquas PowerFlow Tube Set — Class II medical device recall Z-0094-2021
Ongoing recall by Genicon, Inc., reported 2020-10-21, distributed nationwide. The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the ha
| Recall number | Z-0094-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genicon, Inc., Winter Park, FL, United States |
| Recall initiated | 2020-08-25 |
| Classified | 2020-10-09 |
| Reported by FDA | 2020-10-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, EC, HK, JO, KW, QA, SA, ZA |
| Quantity | 10,808 units |
| Lot numbers | I8873-D, I8881-D, I9057-D, I9058-D, I9209-D, I9213-D, I9214-C, 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 |
| Model numbers | 720-005-000, 720-005-001 |
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
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0094-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.