ROi CPS Custom Procedure Packs: Gauze Sponges May Flake or Fray
ROi CPS recalls custom procedure packs with banded 4x4 Raytec 16ply gauze sponges that may flake or fray. Affected items include specific models and lot numbers listed in the recall notice.
Lower-risk recall
Gauze sponges contained in custom kits may be flaking or fraying.
Contact the company
What happened, in plain English
ROi CPS is recalling custom procedure packs that contain banded 4x4 Raytec 16ply gauze sponges. These sponges may flake or fray, which could lead to skin irritation or infection if used improperly. Read more at govinfonow.com/recall/63952-roi-cps-custom-procedure-packs-gauze-sponges-may-flake-or.
Source Summary by GovInfoNow · govinfonow.com/recall/63952-roi-cps-custom-procedure-packs-gauze-sponges-may-flake-or · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0737-2021
Cite this page
“ROi CPS Custom Procedure Packs: Gauze Sponges May Flake or Fray.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63952-roi-cps-custom-procedure-packs-gauze-sponges-may-flake-or. Based on FDA recall #Z-0737-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0737-2021%22&limit=1).
Why it’s dangerous
The gauze sponges in the packs can flake or fray, potentially causing skin irritation or infection if they break off during medical procedures. This is a minor hazard that does not pose a serious injury risk under normal use.
Who’s affected
Healthcare professionals who use these custom procedure packs for medical procedures are most likely affected. Patients using the packs during surgeries or medical treatments may also be at risk if the sponges become flaky or frayed.
How to tell if you have this one
Check for custom procedure packs with banded 4x4 Raytec 16ply gauze sponges. Affected items include specific models like 'Regard, PACEMAKER' (Item 800221010, Lot #82466) and other listed items with corresponding lot numbers.
- Brand
ROi CPS- Category
Medical device
What to do — step by step
Check Product Details
Identify the specific model and lot number of the custom procedure pack to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “US Domestic Distribution Only: MO, NC, LA and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Louisiana, Missouri, North Carolina.
Recall timeline
FDA terminated this recall 6 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-0737-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0737-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.