DeRoyal ENDOVASCULAR TRACEPACK — Class II medical device recall Z-0649-2023
Ongoing recall by DeRoyal Industries Inc, reported 2022-12-21, distributed in AL, AZ, CT, FL, GA, IL, IN, KS…. XXX
| Recall number | Z-0649-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2022-11-03 |
| Classified | 2022-12-15 |
| Reported by FDA | 2022-12-21 |
| Distributed | AL, AZ, CT, FL, GA, IL, IN, KS, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, PA, TN, TX, VA, WI |
| Quantity | 495 kits |
| Lot numbers | 56225516, 56395460, 56620751, 56780958, 57190141, 57754751 |
| Model numbers | 89-9350.03 |
| Expiration dates | 2024-06-01, 2024-10-01, 2025-01-01 |
Product
DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
Reason for recall
XXX
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-0649-2023. 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.