Aquilex Fluid Control System-Intended to provide fluid distension of… — Class II medical device recall Z-2629-2023
Ongoing recall by WOM World Of Medicine AG, reported 2023-10-04, distributed nationwide. The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume disp
| Recall number | Z-2629-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | WOM World Of Medicine AG, Ludwigsstadt, N/A, Germany |
| Recall initiated | 2023-07-17 |
| Classified | 2023-09-22 |
| Reported by FDA | 2023-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, DE, ES, FR, GB, IE, KW, NL, NO, NZ, QA, SE, TR |
| Quantity | 1,287 units |
| UPC / GTIN / UDI-DI | 04056702006914 |
| Serial numbers | 1802CE0539, 1802CE0540, 1802CE0542, 1802CE0543, 1802CE0544, 1802CE0545, 1802CE0546, 1802CE0547, 1802CE0616, 1802CE0617, 1802CE0618, 1802CE0619, 1802CE0620, 1802CE0621, 1802CE0622, 1802CE0624, 1802CE0625, 1802CE0648, 1802CE0649, 1802CE0651, 1802CE0652, 1802CE0653, 1802CE0654, 1802CE0655, 1802CE0656 and 475 more |
| Model numbers | AQL-100P, AQL-100PBS |
Product
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
Reason for recall
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
Machine access
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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.