Covidien HysteroLux Fluid Management System Control Unit
Medical device recall Z-2561-2021. Published in FDA’s Enforcement Report on Oct 6, 2021.
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 6, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1100 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
1100, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1709VG0832 1803CE0680 1803CE0681 1803CE0682 1803CE0683 1803CE0684 1803CE0685 1803CE0686 1803CE0687 1803CE0688 1803CE0689 1803CE1024 1803CE1025 1803CE1026 1803CE1027 1803CE1028 1803CE1029 1803CE1030 1803CE1031 1803CE1032…
Every code shown here, 1,996 characters
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 1804CE0171 1804CE0172 1804CE0173 1804CE0174 1804CE0175 1804CE0176 1804CE0177 1804CE0178 1804CE0179 1804CE0180 1804CE0292 1804CE0293 1804CE0294 1804CE0295 1804CE0296 1804CE0297 1804CE0298 1804CE0299 1804CE0300 1804CE0301 1805CE0298 1805CE0299 1805CE0300 1805CE0301 1805CE0302 1805CE0303 1805CE0304 1805CE0305 1805CE0306 1805CE0307 1805CE0362 1805CE0363 1805CE0364 1805CE0365 1805CE0366 1805CE0367 1805CE0368 1805CE0369 1805CE0370 1805CE0371 1805CE0805 1805CE0806 1805CE0807 1805CE0808 1805CE0809 1805CE0810 1805CE0811 1805CE0812 1805CE0813 1805CE0814 1806CE0013 1806CE0014 1806CE0015 1806CE0016 1806CE0017 1806CE0018 1806CE0019 1806CE0020 1806CE0021 1806CE0022 1806CE0318 1806CE0319 1806CE0320 1806CE0321 1806CE0322 1806CE0323 1806CE0324 1806CE0325 1806CE0326 1806CE0327 1806CE0328 1806CE0329 1806CE0330 1806CE0331 1806CE0332 1806CE0333 1806CE0334 1806CE0335 1806CE0336 1806CE0337 1807CE0343 1807CE0344 1807CE0345 1807CE0346 1807CE0347 1807CE0348 1807CE0349 1807CE0350 1807CE0351 1807CE0425 1807CE0426 1807CE0427 1807CE0428 1807CE0429 1807CE0430 1807CE0431 1807CE0432 1807CE0433 1807CE0434 1807CE0467 1807CE0468 1807CE0469 1807CE0470 1807CE0471 1807CE0472 1807CE0473 1807CE0474 1807CE0475 1807CE0476 1807CE0551 1807CE0552 1807CE0553 1807CE0554 1807CE0555 1807CE0556 1807CE0557 1807CE0558 1807CE0559 1807CE0560 1807CE0601 1807CE0602 1807CE0603 1807CE0604 1807CE0605 1807CE0606 1807CE0607 1807CE0608 1807CE0609 1807CE0610 1807CE0658 1807CE0659 1807CE0660 1807CE0661 1807CE0662 1807CE0663 1807CE0664 1807CE0665 1807CE0666 1807CE0667 1807CE0825 1807CE0826 1807CE0827 1807CE0828 1807CE0829 1807CE0830 1807CE0831 1807CE0832 1807CE0833 1807CE0834 1807CE0915 1807CE0916 1807CE0917 1807CE0918 1807CE0919 1807CE0920…
FDA’s list runs to 12,115 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 in the state of CT.
The states and territories these words name
- Connecticut
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?
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 Jun 18, 2021.
- FDA classified it on Sep 24, 2021.
- FDA’s Enforcement Report published it on Oct 6, 2021.
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: E-Mail.
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 12,115 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
-
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.