DeRoyal Industries Inc: Medical Device Recall in 2025 - (Recall #: Z-1291-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement

Product Classification:

Class II

Date Initiated: January 31, 2025
Date Posted: March 12, 2025
Recall Number: Z-1291-2025
Event ID: 96261
Reason for Recall:

Due 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.

Status: Ongoing
Product Quantity: 714 cases
Code Information:

71-C5100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578738 Lot Number: CNWKD04-04 71-C6100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578851 Lot Numbers: CNWKD04-04 CNWKD04-05 CNWKD04-10 CNWKD09-08 71-C7100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578967 Lot Numbers: CNWKD04-06 CNWKD04-07

Distribution Pattern:

U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

Voluntary or Mandated:

Voluntary: Firm initiated