Z-2699-2020Class II

regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG -

Name: Z-2699-2020 regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG -
Creator: Resource Optimization & Innovation LLC
Published: 2020-06-17
License: https://open.fda.gov/license/

Resource Optimization & Innovation, LLC / initiated 2020-06-17 / Terminated

FDA source

Resource Optimization & Innovation LLC began a recall of regard Migrating Indicator, STEAM Migrating Indicator Strips, REORDER # 335576REG - Product Usage: The integrating indicator is designed to chemically react... on 2020-06-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2699-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-17
Posted: 2020-07-24
Terminated: 2022-07-29
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.
Product code: JOJ Indicator, Physical/Chemical Sterilization Process
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.
FDA 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 in commerce: 66 cases of 12,000 units per case
Distribution: US Nationwide distribution including in the states of MO, NC, AR, OK.
Product codes and lots: Lot 719

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2699-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2699-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-05	2020-07-24

Product code JOJ

K982188Class IISteri-Pak Bowie Dick Test PackSteritec Products Mfg Co, Inc. / cleared 1998-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)