Class II — JosNoe Medical, Inc.
| Recalling firm | JosNoe Medical, Inc. |
|---|---|
| Registered facility | JosNoe Medical Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Damage to package seals potentially compromising sterility. |
| Product | PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery. |
| Quantity | 1008 boxes |
| Distribution | Distributed US (nationwide) and in Canada. |
| Initiated | 2015-12-01 |
| Classified | 2016-01-30 |
| Terminated | 2016-03-22 |
| Recall number | Z-0732-2016 |
| 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 — JosNoe Medical, Inc. (Z-0732-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73007/
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