Class II — Exsurco Medical
| Recalling firm | Exsurco Medical, Inc. |
|---|---|
| Registered facility | EXSURCO MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 |
| Quantity | 70 coaxial hoses |
| Distribution | CA, GA, MO, OH & TX |
| Initiated | 2018-04-17 |
| Classified | 2018-06-26 |
| Terminated | 2020-06-15 |
| Recall number | Z-2291-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Exsurco Medical (Z-2291-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80300/
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