UnratedMedical device recall · FDA · Published December 18, 2023
ROi CPS Surgical Convenience Kit Recall: Component Recalled by Nurse Assist
ROi CPS recalls surgical convenience kits (Item 800943001) due to a component previously recalled by Nurse Assist. Affected kits have specific lot numbers and UDI/DI codes.
“ROi CPS Surgical Convenience Kit Recall: Component Recalled by Nurse Assist.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56548-roi-cps-surgical-convenience-kit-recall-component-recalled-by-nurse. Based on FDA recall #Z-0620-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0620-2024%22&limit=1).
ROi CPS LLC voluntarily recalled surgical convenience kits distributed to Louisiana due to manufacturing issues with a component previously recalled by Nurse Assist, the FDA said on Dec. 18, 2023. The recall involves 345 units of the regard Operative LAP kit.
How to tell if you have it
Brand: ROi CPS
Product: regard Operative LAP, Item Number 800943001; surgical convenience kit
UDI/DI: 10194717111863
Lot Numbers: 94792, 95613, 96003, 96845
Quantity: 345 units
The hazard
The surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Recent brand recalls include the Dec. 26, 2024 Newborn Kit Recall for risk of ineffective ventilation and the July 24, 2024 Medical Convenience Kits Recall involving Merit syringes. Other recent recalls of similar products include Medline Convenience Kits Recall (July 10, 2026) and Medline C-Section Kits Recall (July 10, 2026).
How to tell if you have this one
Check for the item number 800943001 on the kit. Look for lot numbers 94792, 95613, 96003, or 96845 and UDI/DI code 10194717111863.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Identify the item number, lot numbers, and UDI/DI code to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed in Louisiana.
Listed by the agency
Not listed
FDA distribution: “US distribution to Louisiana” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Louisiana.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-0620-2024 (December 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0620-2024 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.