Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 4, 2023
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
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 cou…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Wom World Of Medicine Ag recalled Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during di… - a moderate-severity action.
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during di… was recalled by Wom World Of Medicine Ag in October 4, 2023. Reason: The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume dis…. Check the official notice for the remedy. Verify recall #Z-2629-2023 with the FDA Devices before acting.
The recall
Wom World Of Medicine Ag issued this moderate-severity FDA Devices recall-The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume dis….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- October 4, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2629-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2629-2023) was formally reported on October 4, 2023, with the manufacturer initiating the action on July 17, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wom World Of Medicine Ag is listed as the recalling firm, operating out of Ludwigsstadt, N/A. Federal records list the affected scope as 1287 units.
The documented reason for this recall is: 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 an… Distribution data in the federal record shows the product reached: Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1287 units
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2629-2023 |
| Date reported | October 4, 2023 |
| Date initiated | July 17, 2023 |
| Recalling firm | Wom World Of Medicine Ag |
| Firm location | Ludwigsstadt, N/A |
| Affected scope | 1287 units |
| Distribution | Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2629-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Wom World Of Medicine Ag. Units affected: 1287 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 4, 2023. Severity: Moderate. Recall number: Z-2629-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2629-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 4, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.