# FDA recall Z-1291-2025

> **DeRoyal Industries Inc** · Class II · device recall initiated 2025-01-31.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1291-2025
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-31
- **Report date:** 2025-03-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2025

## Citation

> AI Analytics. FDA recall Z-1291-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1291-2025. Source: US FDA. Licensed CC0.

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