Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog… — Class II medical device recall Z-1686-2024
Ongoing recall by Electro Medical Systems SA, reported 2024-05-01, distributed nationwide. Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts w
| Recall number | Z-1686-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Electro Medical Systems SA, Nyon, N/A, Switzerland |
| Recall initiated | 2024-03-13 |
| Classified | 2024-04-24 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BG, BH, BR, CA, CH, CN, CZ, DE, EG, ES, FR, GB, GR, HK, HU, ID, IL, IT, JO, JP, KE, KR, KW, LU, MX, MY, NL, NZ, OM, PH, PL, QA, RO, SA, SE, SG, SI, TH, TR, UA, VN, ZA |
| Quantity | 342 |
| UPC / GTIN / UDI-DI | 07613353180225, 07613353184124, 07613353184148, 07613353213183 |
| Lot numbers | 16442-210, 2026-04 |
| Serial numbers | EG-1000A, KU21767, KU21778, KU21884, KU21915, KU21948, KU21972, KU21990, KU21991, KU22135, KU22136, KU22137, KU22138, KU22139, KU22140, KU22141, KU22142, KU22143, KU22146, KU22147, KU22165, KU22166, KU22167, KU22168, KU22169 and 318 more |
| Model numbers | EG-1000 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1686-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.