“ROi CPS Regard Dressing Change Tray Recall: Package Integrity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62903-roi-cps-regard-dressing-change-tray-recall-package-integrity-risk. Based on FDA recall #Z-1542-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1542-2021%22&limit=1).
ROi CPS LLC voluntarily recalled Regard Dressing Change Trays distributed in Louisiana due to potential microbial growth from compromised ChloraPrep applicator packaging integrity, according to the FDA on March 26, 2021.
How to tell if you have it
Brand: ROi CPS
Product: Regard Dressing Change Tray
Lot Numbers: 86983C, 87081C, 86356C
Quantity: 272 trays
The hazard
The ChloraPrep applicators in the kits can grow organisms that result in a breach of the applicators package integrity.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Other recent recalls of similar products include Medline PowerGlide Dressing Kits Recall: Open Seal Risk (Dec. 24, 2025), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026) and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).
How to tell if you have this one
Check the lot number on the Regard Dressing Change Tray packaging. The affected lot numbers are 86983C, 87081C, and 86356C.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Identify the lot number on the Regard Dressing Change Tray packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of Louisiana.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1542-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1542-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.