Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE
Medical device recall Z-1686-2024. Published in FDA’s Enforcement Report on May 1, 2024.
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 May 1, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 342 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?
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
342, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers:…
Every code shown here, 1,998 characters
Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23665 KU23668 KU23669 KU23670 KU23671 KU23673 KU23674 KU23675 KU23676 KU23677 KU23679 KU23680 KU23681 KU23682 KU23683 KU23684 KU23685 KU23687 KU23690 KU23691 KU23692 KU23693 KU23694 KU23695 KU23696 KU23697 KU23698 KU23699 KU23702 KU23704 KU23705 KU23707 KU23708 KU23709 KU23710 KU23711 KU23712 KU23713 KU23714 KU23715 KU23717 KU23718 KU23720 KU23721 KU23723 KU23724 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05100 LD05101 LD05102 LD05103 LD05104 LD05105 LD05106 LD05107 LD05108 LD05109 LD05110 LD05111 LD05112 LD05113 LD05114 LD05115 KU23666 KU23667 KU23672 KU23678 KU23686 KU23688 KU23689 KU23700 KU23701 KU23703 KU23706 KU23722 KU24328 KU24341 KU23716 KU23719 KU24342 KU24343 KU24344 KU24345 KU24346 KU24347 KU24348 KU24349 KU24350 KU24351 LD05116 LD05117 LD05118 LD05119 LD05120 LD05121 LD05122 LD05513 LD05514 LD05516 LD05517 LD05518 LD05519 LD05520 LD05521 LD05522 LD05523 LD05524 LD05525 LD05526 LD05527 LD05528 LD05529 LD05530 LD05531 LD05532 LD05533 LD05534 LD05535 KU21778 KU21884 KU21915 KU21948 KU21972 KU22135 KU22136 KU22137 KU22138 KU22139 KU22140 KU22141 KU22142 KU22143 KU22146 KU22147 KU22165 KU22166 KU22167 KU22168 KU22169 KU22170 KU22171 KU22172 KU22173 KU22174 KU22175 KU22176 KU22177 KU22178 LD05038 LD05039 LD05041 LD05042 KU21767 KU21990 KU21991 KU22592 KU23365 KU23366 KU23367 KU23368 KU23369 KU23370 KU23371 KU23372 KU23373 KU23374 KU23375 KU23376 KU23378 KU23379 KU23381 KU23382 LD05093 LD05536 LD05094 LD05095 LD05096 KU23023 KU23026 KU23027 KU23029 KU23030 KU23031 KU23032 KU23064 KU23112 KU23119 KU23120 KU23123 KU23128 KU23131 KU23132 KU23252 KU23263 KU23264 KU23265 KU23266 KU23267 KU23268 KU23269 KU23270 KU23271 KU23272 KU23273 KU23275 KU23276 KU23277 KU23278 KU23279 KU23280 KU23281 KU23282 KU23283 KU23284 KU23289…
FDA’s list runs to 2,991 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.
Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, NETHERLANDS, NEW ZEALAND, OMAN, PALESTINE, PHILIPPINES, POLAND, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, Thailand, UKRAINE,UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VIETNAM.
The states and territories these words name
- Illinois
- Texas
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 Mar 13, 2024.
- FDA classified it on Apr 24, 2024.
- FDA’s Enforcement Report published it on May 1, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Electro Medical Systems SA, of Nyon, Switzerland.
- 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 2,991 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.