RegWardenFDA facility compliance records
Recall

Class II — DeRoyal Industries Inc

Recalling firmDEROYAL INDUSTRIES, INC.
Registered facilityView this company's 13 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonDue to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
ProductDeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Quantity714 cases
DistributionU.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
Initiated2025-01-31
Classified2025-03-05
Recall numberZ-1291-2025
InitiationVoluntary: 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-1291-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96261/

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