FDA Device recall Z-2699-2020
regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to…
- FDA Device
- Class II
- terminated
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to… by Resource Optimization And Innovation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2699-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-17 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Resource Optimization And Innovation |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot 719 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2699-2020%22
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