Lower riskMedical device recall · FDA · Published August 14, 2019
WOM World of Medicine recalls Aquilex Fluid Control System Bag Deflector for inaccurate
WOM World of Medicine recalls Aquilex Fluid Control System Bag Deflector (REF AQL-100CBS) due to potential inaccurate fluid deficit readings during hysteroscopy procedures.
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
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📍Recalling firmWOM World of Medicine AGSalzufer 8 · Berlin, Germany
✎ GovInfoNow plain-language explainer
WOM World of Medicine is recalling a specific component of their Aquilex Fluid Control System called the Bag Deflector (REF AQL-100CBS). This part can display a fluid deficit that differs from the actual amount, which may pose a risk to patients during hysteroscopy procedures. Read more at govinfonow.com/recall/67220-wom-world-of-medicine-recalls-aquilex-fluid-control-system-bag.
“WOM World of Medicine recalls Aquilex Fluid Control System Bag Deflector for inaccurate.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67220-wom-world-of-medicine-recalls-aquilex-fluid-control-system-bag. Based on FDA recall #Z-2767-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2767-2019%22&limit=1).
The Food and Drug Administration announced on August 14, 2019, that WOM World of Medicine AG is recalling the Aquilex Fluid Control System component: Bag deflector (REF AQL-100CBS). The agency stated the pump's displayed deficit may differ from the real deficit, potentially leading to patient risk.
How to tell if you have it
Brand: WOM World of Medicine
Product: Aquilex Fluid Control System component: Bag deflector
REF: AQL-100CBS
UDI: 04056702006556
Units affected: 322
The hazard
According to the FDA, the deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk. The product is used to distend the uterus with fluid during diagnostic and operative hysteroscopies.
Context
GovInfoNow's records show WOM World Of Medicine AG has issued four other recalls since October 22, 2018. On May 24, 2024, the company recalled a Tube Set due to incorrect RFID data causing surgery delays. A July 17, 2023 recall of the Aquilex Fluid Control System cited a display freeze that could cause fluid overload. Other recent recalls of similar products include a June 18, 2021 recall of the Covidien HysteroLux Fluid Management System Control Unit for display freezing and an August 18, 2026 recall of Presource Gyn Laparoscopy Kits for potential fluid leaks.
How to tell if you have this one
Check for the product reference code AQL-100CBS on the Bag Deflector. The serial numbers listed in the recall include specific patterns starting with 1802CE through 1809CE.
Brand
WOM World of Medicine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Serial Number
Look for the serial numbers listed in the recall (e.g., 1802CE0558, 1803CE0226, etc.) on the Bag Deflector component.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2767-2019 (August 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2767-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.