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 | The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use. |
| Product | regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. |
| Quantity | 66 cases of 12,000 units per case |
| Distribution | US Nationwide distribution including in the states of MO, NC, AR, OK. |
| Initiated | 2020-06-17 |
| Classified | 2020-07-24 |
| Terminated | 2022-07-29 |
| Recall number | Z-2699-2020 |
| 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-2699-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85907/
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