CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report

regard Major EAR, ET00326J recalled by ROi CPS

ROi CPS is recalling regard Major EAR, ET00326J, distributed in Florida, Louisiana, Missouri, North Carolina. The recall was initiated on 20 Oct 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

Quantity recalled200 kits

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-0293-2023
FDA event ID: 91069
Recalling firm: ROi CPS, Republic, MO
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2022
FDA classified: 23 Nov 2022
Reported: 30 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Oct 2022	Recall initiated by company
23 Nov 2022	Classified by FDA	+34 days
30 Nov 2022	Published in enforcement report	+7 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 distributed containing 3M surgical drapes which were subsequently recalled.

Product as listed by the FDA

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

Where it was distributed

LA, MO, NC, FL

Florida Louisiana Missouri North Carolina

Questions about this recall

Is regard Major EAR, ET00326J recalled?

Yes. ROi CPS recalled regard Major EAR, ET00326J on 20 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0293-2023.

Why was it recalled?

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Which lots are affected?

UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

Where was it sold?

LA, MO, NC, FL

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

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