Z-0255-2022Class II

REGARD Ultrasound Tray

Name: Z-0255-2022 REGARD Ultrasound Tray
Creator: ROi CPS LLC
Published: 2021-08-10
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-08-10 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of REGARD Ultrasound Tray on 2021-08-10. FDA classified it as Class II and gives the reason as "Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0255-2022
Classification: Class II
Status: Terminated
Initiated: 2021-08-10
Posted: 2021-11-18
Terminated: 2023-06-16
Recalling firm: ROi CPS LLC
Product: REGARD Ultrasound Tray
Product code: OIP Radiology-Diagnostic Kit
Reason for recall: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The correction was sent via e-mail on 08-10-2021 instructing the consignees to removed the Swabsticks (3's) and be discarded at time of use.
Quantity in commerce: 240 trays
Distribution: US Nationwide in the states of FL, LA and MO.
Product codes and lots: Lots numbers: 87414C, 87035C, 86918C, 88755C and 85539C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0255-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0250-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0251-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0252-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0253-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0254-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0255-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0256-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code OIP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)