Aquilex Fluid Control System component: Bag deflector — Class II medical device recall Z-2767-2019
Terminated recall by WOM World of Medicine AG, reported 2019-10-09, distributed nationwide. The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
| Recall number | Z-2767-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | WOM World of Medicine AG, Berlin, N/A, Germany |
| Recall initiated | 2019-08-14 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 322 units |
| UPC / GTIN / UDI-DI | 04056702006556 |
| Serial numbers | 1802CE0558, 1802CE0559, 1802CE0560, 1802CE0561, 1802CE0562, 1802CE0563, 1802CE0564, 1802CE0565, 1802CE0566, 1802CE0567, 1803CE0024, 1803CE0025, 1803CE0026, 1803CE0027, 1803CE0028, 1803CE0029, 1803CE0030, 1803CE0031, 1803CE0032, 1803CE0033, 1803CE0064, 1803CE0065, 1803CE0066, 1803CE0067, 1803CE0068 and 475 more |
| Model numbers | AQL-100CBS |
Product
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Reason for recall
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
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-2767-2019. 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.