Aquilex Fluid Control System component: Bag deflector
Medical device recall Z-2767-2019. Published in FDA’s Enforcement Report on Oct 9, 2019.
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 9, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 322 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 deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
322 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 04056702006556 Serial Numbers: 1802CE0558 1803CE0226 1803CE0835 1804CE0075 1804CE0487 1804CE0912 1805CE0592 1802CE0559 1803CE0227 1803CE0869 1804CE0153 1804CE0488 1804CE0913 1805CE0593 1802CE0560 1803CE0228 1803CE0870 1804CE0154…
Every code shown here, 1,994 characters
UDI: 04056702006556 Serial Numbers: 1802CE0558 1803CE0226 1803CE0835 1804CE0075 1804CE0487 1804CE0912 1805CE0592 1802CE0559 1803CE0227 1803CE0869 1804CE0153 1804CE0488 1804CE0913 1805CE0593 1802CE0560 1803CE0228 1803CE0870 1804CE0154 1804CE0489 1804CE0914 1805CE0594 1802CE0561 1803CE0229 1803CE0871 1804CE0155 1804CE0490 1804CE0915 1805CE0595 1802CE0562 1803CE0230 1803CE0872 1804CE0156 1804CE0491 1804CE0916 1805CE0596 1802CE0563 1803CE0231 1803CE0873 1804CE0157 1804CE0492 1804CE0917 1805CE0597 1802CE0564 1803CE0232 1803CE0874 1804CE0158 1804CE0493 1804CE0918 1805CE0598 1802CE0565 1803CE0233 1803CE0875 1804CE0159 1804CE0494 1804CE0919 1805CE0599 1802CE0566 1803CE0234 1803CE0876 1804CE0160 1804CE0495 1804CE0920 1805CE0600 1802CE0567 1803CE0235 1803CE0877 1804CE0212 1804CE0648 1805CE0031 1805CE0640 1803CE0024 1806CE0520 1803CE0878 1804CE0213 1804CE0649 1805CE0032 1805CE0641 1803CE0025 1803CE0498 1803CE0926 1804CE0214 1804CE0650 1805CE0033 1805CE0642 1803CE0026 1803CE0499 1803CE0927 1804CE0215 1804CE0651 1805CE0034 1805CE0643 1803CE0027 1803CE0500 1803CE0928 1804CE0216 1804CE0652 1805CE0035 1805CE0644 1803CE0028 1803CE0501 1803CE0929 1804CE0217 1804CE0653 1805CE0036 1805CE0645 1803CE0029 1803CE0502 1803CE0930 1804CE0218 1804CE0654 1805CE0037 1805CE0646 1803CE0030 1803CE0503 1803CE0931 1804CE0219 1804CE0655 1805CE0038 1805CE0647 1803CE0031 1803CE0504 1803CE0932 1804CE0220 1804CE0656 1805CE0039 1805CE0648 1803CE0032 1803CE0505 1803CE0933 1804CE0221 1804CE0657 1805CE0040 1805CE0649 1803CE0033 1803CE0506 1803CE0934 1804CE0260 1804CE0737 1805CE0099 1805CE0742 1803CE0064 1803CE0507 1803CE0935 1804CE0261 1804CE0738 1805CE0100 1805CE0743 1803CE0065 1803CE0562 1803CE1118 1804CE0262 1804CE0739 1805CE0101 1805CE0744 1803CE0066 1803CE0563 1803CE1119 1804CE0263 1804CE0740 1805CE0102 1805CE0745 1803CE0067 1803CE0564 1803CE1120 1804CE0264 1804CE0741 1805CE0103 1805CE0746 1803CE0068 1803CE0565 1803CE1121 1804CE0265 1804CE0742 1805CE0104 1805CE0747 1803CE0069 1803CE0566 1803CE1122…
FDA’s list runs to 5,623 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.
US Nationwide Distribution
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Aug 14, 2019.
- FDA classified it on Sep 30, 2019.
- FDA’s Enforcement Report published it on Oct 9, 2019.
- FDA terminated it on May 20, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- WOM World of Medicine AG, of Berlin, 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 5,623 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.