CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Brand Name: Piezon Bottle Product Name: Piezon Bottle Model/Catalog recalled
Electro Medical Systems is recalling Brand Name: Piezon Bottle Product Name: Piezon Bottle Model/Catalog, distributed nationwide in the US. The recall was initiated on 13 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1688-2024
- FDA event ID
- 94293
- Recalling firm
- Electro Medical Systems, Nyon, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2024
- FDA classified
- 24 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 13 Mar 2024 | Recall initiated by company | |
| 24 Apr 2024 | Classified by FDA | +42 days |
| 1 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Lot Code: Model number: EG-111, UDI: 07613353180249 Lot number: 16442-190, Expiry date: 2026-04 Model number: EG-111, UDI: 07613353180249 Lot number: 16694-30 Expiry date: 2026-07 AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: KU23667 KU23689 KU23700 KU23701 KU23703 KU23722 KU24328 KU24330 KU24331 KU24333 KU24334 KU24335 KU24337 KU24339 KU24340 KU24341 KU23719 KU24336 KU24338 KU24342 KU24344 KU24346 KU24349 KU24354 KU24356 KU23666 KU23672 KU23678 KU23686 KU23688 KU23706 KU23716 KU24343 KU24345 KU24347 KU24348 KU24350 KU24351 KU24353 KU24355 KU24357 KU24363 KU24366 KU24367 KU24368 KU24369 KU24370 KU24371 KU24372 KU24373 KU24359 KU24360 KU24361 KU24365
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94293This product is part of a recall event; the main page for the event is Brand Name: Water Bottle Product Name: Water Bottle Model/Catalog recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Brand Name: Water Bottle Product Name: Water Bottle Model/Catalog recalled | Electro Medical Systems | Device Malfunction | Nationwide | |
| CLASS II | Brand Name: Cleaner Bottle Product Name recalled | Electro Medical Systems | Device Malfunction | Nationwide |
More recalls from Electro Medical Systems
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brand Name: Cleaner Bottle Product Name recalled | Electro Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Brand Name: Water Bottle Product Name: Water Bottle Model/Catalog recalled | Electro Medical Systems | Device Malfunction | Nationwide |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |