Resource Optimization & Innovation LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Resource Optimization & Innovation LLC
Lot Codes / Batch Numbers
Lot 719
Products Sold
Lot 719
Resource Optimization & Innovation LLC is recalling regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: T due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm initiated the recall by email on 06/17/2020. The letter requested the customer quarantine any product and notify the firm. ROi, LLC will facility the return of the product. The letter also directed the customer notify all potential users how may have received the recalled item.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026