ROi CPS Regard Sterilized Kits Recall: Missing Safety Label
ROi CPS recalls sterilized convenience kits with missing rubber latex warning labels. Affected kits may not alert users to latex allergy risks. Contact for replacement.
Lower-risk recall
Kits lacks rubber latex warning label.
Contact the company
What happened, in plain English
ROi CPS is recalling sterilized convenience kits that lack a rubber latex warning label. This could mean users with latex allergies aren't warned about potential reactions. The recall is for specific model numbers and expiration dates. Read more at govinfonow.com/recall/61488-roi-cps-regard-sterilized-kits-recall-missing-safety-label.
Source Summary by GovInfoNow · govinfonow.com/recall/61488-roi-cps-regard-sterilized-kits-recall-missing-safety-label · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0469-2022
Cite this page
“ROi CPS Regard Sterilized Kits Recall: Missing Safety Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61488-roi-cps-regard-sterilized-kits-recall-missing-safety-label. Based on FDA recall #Z-0469-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0469-2022%22&limit=1).
Why it’s dangerous
The kits lack a rubber latex warning label, which is critical for users with latex allergies. Without this label, users might not know they could have an allergic reaction if they come into contact with latex materials. This is a labeling issue, not a physical defect in the kits.
Who’s affected
Users of the Regard sterilized convenience kits with specific model numbers and expiration dates are affected. Those with latex allergies are at higher risk due to the missing warning label.
How to tell if you have this one
Check for model numbers 8800313004 (Lot 89090D, expires 07/15/2023) or 8800313005 (Lot 89378, expires 08/05/2023). The kits are sterilized convenience kits from ROi CPS.
- Brand
ROi CPS- Category
Medical device
What to do — step by step
Check Label
Look for a rubber latex warning label on the kit. If missing, it's part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0469-2022 (November 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0469-2022 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.