Brand Name: WATER BOTTLE Product Name: WATER BOTTLE
Medical device recall Z-1687-2024. 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
- 462 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: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
462, 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-121, UDI: 07613353180287 Lot number: 16457-10, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-80, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number:…
Every code shown here, 1,995 characters
Lot Code: Model number: EG-121, UDI: 07613353180287 Lot number: 16457-10, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-80, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-120, Expiry date: 2026-07 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-130, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-140, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16866-80, Expiry date: 2026-10: batch not impacted by the deviation, but as the expiry date is the same than other batches impacted it was decided to recall this batch as well because the expiry date is engraved on the bottles and the user might not be able to differentiate the batch number if the packaging was disposed of. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: LD04753 LD04757 LG10166 LG10167 LG10168 LG10169 LG10170 LG10171 LG10172 LG10173 LG10174 LG10175 LG10151 LG10152 LG10153 LG10154 LG10155 LG10156 LG10157 LG10158 LG10159 LG10160 LG10161 LG10162 LG10163 LG10164 LG10165 OF-04-05367-1 LG10413 LG10414 LG10416 LG10418 LG10421 LG11050 LG11051 LG11052 LG11053 LG11054 LG11055 LG11056 LG11057 LG11127 LG11128 LG11129 LG11130 LG11131 LG11132 LG11133 LG11134 LG11135 LG11136 LG11313 LG11314 LG11315 LG11316 LG11317 LG11318 LG11319 LG11320 LG11321 LG11322 LG11323 LG11324 LG11325 LG11326 LG11327 LG11328 LG11329 LD05012 LD05033 LD05034 LD05035 LD05036 LD05037 LD05038 LD05039 LD05041 LD05042 LD04674 LD04913 LD04914 LD04915 LD04916 LD04917 LG10681 LG10682 LG10683 LG10684 LG10685 LG10686 LG10687 LG10690 LG10691 LG10692 LG10693 LG10694 LG10695 LG10696 LG10697 LG10698 LG10699 LG10700 LG10701 LG10702 LG10703 LG10704 LG10705 LG10706 LG10707 LG10908 LG10909 LG10910 LG10911 LG10912 LG10913 LG10914 LG10915 LG10916 LG10917 LG10918 LG10919 LG10920 LG10921 LG10929 LG10930 LG10931 LG10932 LG10933 LG10934…
FDA’s list runs to 4,664 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 4,664 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.