regard Migrating Indicator — Class II medical device recall Z-2699-2020
Terminated recall by Resource Optimization & Innovation LLC, reported 2020-08-05, distributed nationwide. The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go
| Recall number | Z-2699-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation LLC, Saint Louis, MO, United States |
| Recall initiated | 2020-06-17 |
| Classified | 2020-07-24 |
| Reported by FDA | 2020-08-05 |
| Terminated | 2022-07-29 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Lot numbers | 719 |
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.
Reason for recall
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.
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-2699-2020. 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.