Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE… — Class II medical device recall Z-2090-2023
Ongoing recall by DeRoyal Industries Inc, reported 2023-07-12, distributed nationwide. The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
| Recall number | Z-2090-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2023-05-30 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 306 packages |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00749756734080, 00749756736176, 00749756904841, 50749756734085, 50749756736171 |
| Lot numbers | 58741944, 58806701, 58821231 |
| Model numbers | 89-7102, 89-7322, 89-9183 |
Product
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Reason for recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
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-2090-2023. 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.