CLASS I Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

regard Operative LAP recalled by ROi CPS

ROi CPS is recalling regard Operative LAP, distributed in Louisiana. The recall was initiated on 18 Dec 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Quantity recalled345 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0620-2024
FDA event ID: 93653
Recalling firm: ROi CPS, Republic, MO
Classification: Class I
Status: Terminated
Recall initiated: 18 Dec 2023
FDA classified: 12 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

18 Dec 2023	Recall initiated by company
12 Jan 2024	Classified by FDA	+25 days
24 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

Product as listed by the FDA

regard Operative LAP, Item Number 800943001; surgical convenience kit

Where it was distributed

US distribution to Louisiana

Louisiana

Questions about this recall

Is regard Operative LAP recalled?

Yes. ROi CPS recalled regard Operative LAP on 18 Dec 2023. The recall is Class I and its status is Terminated. Recall number Z-0620-2024.

Why was it recalled?

Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.

Which lots are affected?

UDI/DI 10194717111863, Lot Numbers: 94792, 95613, 96003, 96845

Where was it sold?

US distribution to Louisiana

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from ROi CPS

All 86

Reported	Class	Recall	Company	Reason	Where
12 Feb 2025Device	CLASS I	regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled	ROi CPS	Potency & Assay	MO
25 Sep 2024Device	CLASS II	regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled	ROi CPS	Packaging Defects	Nationwide
28 Aug 2024Device	CLASS II	Regard Kit containing the Microtek decanter recalled by ROi CPS	ROi CPS	Sterility	Nationwide
10 Jan 2024Device	CLASS I	Regard Dressing change kit recalled by ROi CPS	ROi CPS	Other	Nationwide
22 Nov 2023Device	CLASS II	Regard CV PK recalled by ROi CPS	ROi CPS	Other	MO

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide