Class II — Resource Optimization & Innovation Llc
| Recalling firm | Resource Optimization & Innovation |
|---|---|
| Registered facility | Resource Optimization & Innovation, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field. |
| Product | Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU |
| Quantity | 660 kits |
| Distribution | US Distribution to LA and TX. |
| Initiated | 2017-01-09 |
| Classified | 2017-03-24 |
| Terminated | 2018-09-28 |
| Recall number | Z-1678-2017 |
| 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 — Resource Optimization & Innovation Llc (Z-1678-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76255/
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