Covidien HysteroLux Fluid Management System Control Unit — Class II medical device recall Z-2561-2021
Ongoing recall by WOM World of Medicine AG, reported 2021-10-06, distributed nationwide. When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit dis
| Recall number | Z-2561-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | WOM World of Medicine AG, Berlin, N/A, Germany |
| Recall initiated | 2021-06-18 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 1,100 |
| Reason classes | software |
| Serial numbers | 1709VG0832, 1803CE0680, 1803CE0681, 1803CE0682, 1803CE0683, 1803CE0684, 1803CE0685, 1803CE0686, 1803CE0687, 1803CE0688, 1803CE0689, 1803CE1024, 1803CE1025, 1803CE1026, 1803CE1027, 1803CE1028, 1803CE1029, 1803CE1030, 1803CE1031, 1803CE1032, 1803CE1033, 1803CE1084, 1803CE1085, 1803CE1086, 1803CE1087 and 475 more |
| Model numbers | 72205000 |
Product
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Reason for recall
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
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.