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 | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes |
| Product | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; … |
| Quantity | 235,785 units |
| Distribution | Worldwide Distribution: US (nationwide) and country of Guatemala. |
| Initiated | 2015-04-27 |
| Classified | 2015-06-25 |
| Terminated | 2015-12-29 |
| Recall number | Z-1837-2015 |
| 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-1837-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71294/
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