Food, drugs, devices › DeRoyal Industries Inc
Device recall: Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, L
DeRoyal Industries Inc (Powell, TN) initiated this device recall on 27 Apr 2015; FDA lists 1 product record under event 71294, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 29 Dec 2015. Initiation: voluntary: firm initiated. DeRoyal Industries Inc has 46 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DeRoyal Industries Inc, Powell, TN.
Reason for recall
"Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes"
Distribution
"Worldwide Distribution: US (nationwide) and country of Guatemala."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1837-2015 | 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;… | 235,785 units | Class II | Terminated | 1 Jul 2015 |
Context
Other enforcement events for DeRoyal Industries Inc
All 46 events for DeRoyal Industries Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (nationwide) and country of Guatemala."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Dec 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.