Class III — Devicor Medical Products Inc
| Recalling firm | Devicor Medical Products, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01. |
| Product | Neoprobe GDS Control Unit, Model Number NPCU3 |
| Quantity | 49 |
| Distribution | The products were distributed only to China. |
| Initiated | 2020-09-07 |
| Classified | 2020-10-08 |
| Terminated | 2023-05-09 |
| Recall number | Z-0070-2021 |
| 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 III recall — Devicor Medical Products Inc (Z-0070-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86228/
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