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RecallWatchMedical Device Safety
Class IIOngoingZ-1174-2025

DeRoyal Industries Inc recalls DeRoyal AMG Suction Connector Tubing REF: 71-2083

DeRoyal Industries IncPowell, TN, United StatesReported Feb 26, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
    UDI-DI code
    91 affected lots
    71-C50654852700749756579032CNWKD04-014/4/2029CWNKD04-024/9/2029CNWKD04-03
    +83 more4/14/2029CNWKD04-044/19/2029CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/2029CNWKD09-029/1/2029CNWKD09-089/13/202971-C510548535CNWKD04-014/4/2029CNWKD04-024/9/2029CNWKD04-034/14/2029CNWKD04-044/19/2024CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/202971-C51254854300749756579063CNWKD04-014/4/2029CNWKD04-024/9/2029CNWKD04-034/14/2029CNWKD04-044/19/2029CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/2029CNWKD09-059/7/2029CNWKD09-079/11/2029CNWKD09-089/13/2029CNWKD10-0510/9/202971-C52054855100749756579070CNWKD04-014/4/2029CNWKD04-044/19/2029CNWKD09-029/1/2029CNWKD10-0610/12/2029

What the firm is doing

On 01/15/2025 the firm sent via email an "URGENT! DEROYAL RECALL NOTICE" letter for the Suction Connector Tubing. The letter was informing customers that the suction connector tubing could be defective and that the tubing may not ensure that the yankauer stays intact, and secure to the tubing/yankauer connection for a tight seal. Customers are instructed to: 1.Search their inventory for the affected products and place them in quarantine to prevent further use. 2. Destroy all affected products and complete the NOTICE OF RETURN FORM and indicate all affected products found in their inventory. Return completed form to DeRoyal via fax to 865-362-3716 or recall@deroyal.com. 3. If customers have questions regarding credit for the recall, contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email at recalls@deroyal.com. If replacement product is preferred, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director at aschubert@deroyal.com

DistributionShow details

U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI, O.U.S.: Kuwait

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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