Class II — 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 II |
| Status | Terminated |
| Reason | The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira. |
| Product | DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala |
| Quantity | 230 units |
| Distribution | Distributed in the states of MI, GA, OH, IL, MO, and IN. |
| Initiated | 2014-06-04 |
| Classified | 2014-07-29 |
| Terminated | 2015-05-05 |
| Recall number | Z-2125-2014 |
| 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 II recall — DeRoyal Industries Inc (Z-2125-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68744/
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