REGARD Ultrasound Tray — Class II medical device recall Z-0255-2022
Terminated recall by ROi CPS LLC, reported 2021-11-24, distributed nationwide. Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a compon
| Recall number | Z-0255-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-08-10 |
| Classified | 2021-11-18 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2023-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 240 trays |
| Reason classes | specification failure |
| Lot numbers | 85539C, 86918C, 87035C, 87414C, 88755C |
Product
REGARD Ultrasound Tray
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0255-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.