Regard Kit containing the Microtek decanter — Class II medical device recall Z-2685-2024
Ongoing recall by ROi CPS LLC, reported 2024-08-28, distributed nationwide. Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
| Recall number | Z-2685-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2024-06-17 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 78 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10194717116677 |
| Lot numbers | 99206 |
| Model numbers | 830099009 |
| Expiration dates | 2024-09-15 |
Product
Regard Kit containing the Microtek decanter
Reason for recall
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
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-2685-2024. 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.