CLASS II Device recall · Reported 5 Aug 2020 · FDA Enforcement Report
regard Migrating Indicator, Steam Migrating Indicator Strips recalled
Resource Optimization & Innovation is recalling regard Migrating Indicator, Steam Migrating Indicator Strips, distributed nationwide in the US. The recall was initiated on 17 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2699-2020
- FDA event ID
- 85907
- Recalling firm
- Resource Optimization & Innovation, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2020
- FDA classified
- 24 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 17 Jun 2020 | Recall initiated by company | |
| 24 Jul 2020 | Classified by FDA | +37 days |
| 5 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution including in the states of MO, NC, AR, OK.
Questions about this recall
Is regard Migrating Indicator, Steam Migrating Indicator Strips recalled?
Yes. Resource Optimization & Innovation recalled regard Migrating Indicator, Steam Migrating Indicator Strips on 17 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2699-2020.
Why was it recalled?
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.
Which lots are affected?
Lot 719
Where was it sold?
US Nationwide distribution including in the states of MO, NC, AR, OK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Resource Optimization & Innovation
All 228| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Regard IV Start Kit for preparing and/or dressing recalled | Resource Optimization & Innovation | Other | MO |
| Device | CLASS II | Regard SRHS GIC Port A Cath, Sterile, Qty recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard SRHS Central Line Kit, Sterile recalled | Resource Optimization & Innovation | Sterility | Nationwide |
| Device | CLASS II | Regard Custom Surgical Pack Packs contain surgical recalled | Resource Optimization & Innovation | Labeling Errors | TX |
| Device | CLASS II | Regard, Item Number: 800558001, Sterile, OR0647A - Extremity recalled | Resource Optimization & Innovation | Sterility | LA, TX |
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