FDA Medical Device Recalls (openFDA)
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 number
- Z-2699-2020
- Recalling firm
- Resource Optimization & Innovation LLC
- 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.
- Status
- Terminated
- Initiated
- 2020-06-17
- Posted
- not on file
- Terminated
- 2022-07-29
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 66 cases of 12,000 units per case
- Distribution
- US Nationwide distribution including in the states of MO, NC, AR, OK.
- Lot, serial or model codes
- Lot 719
- 510(k) numbers
- ["K982188"]
- PMA numbers
- not on file
- Product code
- JOJ
- Firm FEI
- 3004513970
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28