Regard — Class II medical device recall Z-1634-2017
Terminated recall by Resource Optimization & Innovation Llc, reported 2017-04-05, distributed in LA, TX. Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because
| Recall number | Z-1634-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Resource Optimization & Innovation Llc, Springfield, MO, United States |
| Recall initiated | 2017-01-09 |
| Classified | 2017-03-24 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2018-09-28 |
| Distributed | LA, TX |
| Quantity | 25 kits |
| Reason classes | sterility |
| Model numbers | 800569003 |
| Expiration dates | 2018-07-30, 2018-08-30 |
Product
Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
Reason for recall
Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
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-1634-2017. 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.