Regard Custom Surgical Pack — Class II medical device recall Z-2799-2015
Terminated recall by Resource Optimization & Innovation Llc, reported 2015-09-30. Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assuran
| Recall number | Z-2799-2015 |
|---|---|
| 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 | 2015-08-19 |
| Classified | 2015-09-21 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-04-05 |
| Quantity | 67 kits |
| Reason classes | sterility |
| Model numbers | 800208002 |
Product
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures.
Reason for recall
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
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-2799-2015. 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.