Class I — DeRoyal Industries Inc
| Recalling firm | DEROYAL INDUSTRIES, INC. |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine |
| Product | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 |
| Quantity | 12 trays |
| Distribution | US Nationwide distribution to the states of MS, VA, LA, and NY. |
| Initiated | 2021-05-14 |
| Classified | 2021-06-10 |
| Terminated | 2023-04-21 |
| Recall number | Z-1832-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — DeRoyal Industries Inc (Z-1832-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87949/
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