FDA Device recall Z-1686-2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bo…
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bo… by Electro Medical Systems, citing 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 no….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1686-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-13 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Electro Medical Systems |
| Distribution | US |
Product
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
Reason
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).
Identifiers
| code_info | Lot Code: Model number: EG-1000, UDI: 07613353180225, Lot number: 16442-210, Expiry date: 2026-04. AIRFLOW Prophylaxis…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1686-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.