INVUITY — Class II medical device recall Z-2778-2017
Terminated recall by Invuity, Inc., reported 2017-08-02, distributed nationwide. A small number of customer observations were recently received which related to possible unintended energy dis
| Recall number | Z-2778-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Invuity, Inc., San Francisco, CA, United States |
| Recall initiated | 2017-06-12 |
| Classified | 2017-07-27 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2023-06-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,328 units |
| Model numbers | PB1 |
Product
INVUITY(R) PhotonBlade(TM), REF PB1
Reason for recall
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
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-2778-2017. 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.