Amalgatome SD — Class II medical device recall Z-2291-2018
Terminated recall by Exsurco Medical, reported 2018-07-04, distributed in CA, GA, MO, OH, TX. Improper installation of hand piece may result in a weakening of the internal hose connection which can cause
| Recall number | Z-2291-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exsurco Medical, Wakeman, OH, United States |
| Recall initiated | 2018-04-17 |
| Classified | 2018-06-26 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2020-06-15 |
| Distributed | CA, GA, MO, OH, TX |
| Quantity | 70 coaxial |
| UPC / GTIN / UDI-DI | 00201607220017, 00201607220024, 00201607220031, 00201607220048, 00201607220055, 00201607220062, 00201607220079, 00201607220086, 00201607220093, 00201804100105, 00201804100112, 00201804100129 |
| Serial numbers | SDH201607220001, SDH201607220002, SDH201607220003, SDH201607220004, SDH201607220005, SDH201607220006, SDH201607220007, SDH201607220008, SDH201607220009, SDH201607220010, SDH201607220011, SDH201607220012, SDH201607220013, SDH201607220014, SDH201607220015, SDH201607220016, SDH201607220017, SDH201607220018, SDH201607220019, SDH201607220020, SDH201607220021, SDH201607220022, SDH201607220023, SDH201607220024, SDH201607220025 and 104 more |
| Model numbers | X101004 |
Product
Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
Reason for recall
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
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-2291-2018. 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.