Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and…
Medical device recall Z-2629-2023. Published in FDA’s Enforcement Report on Oct 4, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 4, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1287 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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
1287 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 04056702006914 Device Models AQL-100PBS and AQL-100P Serial Numbers: US S1802CE0538 1802CE0539 1802CE0540 1802CE0542 1802CE0543 1802CE0544 1802CE0545 1802CE0546 1802CE0547 1802CE0616 1802CE0617 1802CE0618 1802CE0619 1802CE0620…
Every code shown here, 1,995 characters
UDI-DI: 04056702006914 Device Models AQL-100PBS and AQL-100P Serial Numbers: US S1802CE0538 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 1802CE0657 1803CE0121 1803CE0122 1803CE0123 1803CE0124 1803CE0125 1803CE0126 1803CE0127 1803CE0128 1803CE0129 1803CE0130 1803CE0199 1803CE0201 1803CE0204 1803CE0205 1803CE0295 1803CE0296 1803CE0298 1803CE0299 1803CE0300 1803CE0301 1803CE0302 1803CE0663 1803CE0909 1803CE0910 1803CE0911 1803CE0912 1803CE0913 1803CE0914 1803CE0915 1803CE0916 1803CE0917 1803CE0918 1803CE0984 1803CE0985 1803CE0986 1803CE0987 1803CE0988 1803CE0989 1803CE0990 1803CE0991 1803CE0992 1803CE1014 1803CE1015 1803CE1016 1803CE1017 1803CE1018 1803CE1019 1803CE1020 1803CE1021 1803CE1022 1803CE1023 1803CE1088 1803CE1089 1803CE1090 1803CE1091 1803CE1092 1803CE1093 1803CE1094 1803CE1095 1803CE1096 1803CE1097 1803CE1129 1803CE1131 1803CE1132 1803CE1134 1803CE1135 1803CE1136 1803CE1137 1803CE1178 1803CE1179 1803CE1180 1803CE1181 1803CE1183 1803CE1185 1803CE1186 1803CE1187 1804CE0133 1804CE0134 1804CE0135 1804CE0137 1804CE0138 1804CE0139 1804CE0140 1804CE0142 1804CE0242 1804CE0243 1804CE0244 1804CE0245 1804CE0246 1804CE0247 1804CE0248 1804CE0249 1804CE0312 1804CE0313 1804CE0314 1804CE0316 1804CE0317 1804CE0318 1804CE0319 1804CE0320 1804CE0321 1804CE0402 1804CE0403 1804CE0404 1804CE0405 1804CE0406 1804CE0407 1804CE0408 1804CE0409 1804CE0410 1804CE0446 1804CE0447 1804CE0448 1804CE0449 1804CE0450 1804CE0452 1804CE0453 1804CE0454 1804CE0455 1804CE0541 1804CE0542 1804CE0543 1804CE0544 1804CE0545 1804CE0546 1804CE0547 1804CE0548 1804CE0549 1804CE0550 1804CE0622 1804CE0623 1804CE0624 1804CE0625 1804CE0626 1804CE0749 1804CE0752 1804CE0755 1804CE0801 1804CE0802 1804CE0803 1804CE0804 1804CE0805 1804CE0806 1804CE0807 1804CE0808 1804CE0809 1804CE0810…
FDA’s list runs to 15,261 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 17, 2023.
- FDA classified it on Sep 22, 2023.
- FDA’s Enforcement Report published it on Oct 4, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- WOM World Of Medicine AG, of Ludwigsstadt, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 15,261 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.