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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

DeRoyal AMG Suction Connector Tubing Recalled for Potential Suction Loss

Agency Publication Date: February 14, 2025
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Summary

DeRoyal Industries Inc is recalling approximately 224,770 tubes of DeRoyal AMG Suction Connector Tubing because the tubing may not securely connect to the yankauer (suction tip). This defect can prevent a tight seal, which can lead to inadequate suction during medical procedures. No incidents or injuries have been reported in connection with this issue, but the defect could result in delays in patient care.

Risk

If the tubing does not maintain a secure connection, medical professionals may experience a loss of suction while trying to clear fluids. This can interfere with medical procedures and potentially cause harm by delaying necessary clinical care.

What You Should Do

  1. This recall affects DeRoyal AMG Suction Connector Tubing under various model numbers including 71-2083, 71-2084, 71-C501, 71-C506, 71-C510, 71-C512, and 71-C520.
  2. Identify if you have the affected product by checking the model number and lot number printed on the device packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled suction connector tubing immediately.
  4. Contact DeRoyal Industries Inc or your authorized medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall for replacement or correction.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: DeRoyal AMG Suction Connector Tubing (Model 71-C501 / 71-2083 / 71-2084)
Model / REF:
71-2083
71-2084
71-C501
548501
UDI:
00749756578981

Intended for fluid movement.

Product: DeRoyal AMG Suction Connector Tubing (Model 71-C506)
Model / REF:
71-C506
548527
Lot Numbers:
CNWKD04-01 (exp 4/4/2029)
CWNKD04-02 (exp 4/9/2029)
CNWKD04-03 (exp 4/14/2029)
CNWKD04-04 (exp 4/19/2029)
CNWKD04-05 (exp 4/24/2029)
CNWKD04-06 (exp 4/29/2029)
CNWKD04-07 (exp 5/4/2029)
CNWKD04-08 (exp 5/9/2029)
CNWKD04-09 (exp 5/14/2029)
CNWKD04-10 (exp 5/19/2029)
CNWKD09-02 (exp 9/1/2029)
CNWKD09-08 (exp 9/13/2029)
UDI:
00749756579032
Product: DeRoyal AMG Suction Connector Tubing (Model 71-C510)
Model / REF:
71-C510
548535
Lot Numbers:
CNWKD04-01 (exp 4/4/2029)
CNWKD04-02 (exp 4/9/2029)
CNWKD04-03 (exp 4/14/2029)
CNWKD04-04 (exp 4/19/2024)
CNWKD04-05 (exp 4/24/2029)
CNWKD04-06 (exp 4/29/2029)
CNWKD04-07 (exp 5/4/2029)
CNWKD04-08 (exp 5/9/2029)
CNWKD04-09 (exp 5/14/2029)
CNWKD04-10 (exp 5/19/2029)
UDI:
00749756579049
Product: DeRoyal AMG Suction Connector Tubing (Model 71-C512)
Model / REF:
71-C512
548543
Lot Numbers:
CNWKD04-01 (exp 4/4/2029)
CNWKD04-02 (exp 4/9/2029)
CNWKD04-03 (exp 4/14/2029)
CNWKD04-04 (exp 4/19/2029)
CNWKD04-05 (exp 4/24/2029)
CNWKD04-06 (exp 4/29/2029)
CNWKD04-07 (exp 5/4/2029)
CNWKD04-08 (exp 5/9/2029)
CNWKD04-09 (exp 5/14/2029)
CNWKD04-10 (exp 5/19/2029)
CNWKD09-05 (exp 9/7/2029)
CNWKD09-07 (exp 9/11/2029)
CNWKD09-08 (exp 9/13/2029)
CNWKD10-05 (exp 10/9/2029)
UDI:
00749756579063
Product: DeRoyal AMG Suction Connector Tubing (Model 71-C520)
Model / REF:
71-C520
548551
Lot Numbers:
CNWKD04-01 (exp 4/4/2029)
CNWKD04-04 (exp 4/19/2029)
CNWKD09-02 (exp 9/1/2029)
CNWKD10-06 (exp 10/12/2029)
UDI:
00749756579070

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96130
Status: Active
Manufacturer: DeRoyal Industries Inc
Sold By: Authorized Medical Distributors; Healthcare Facilities
Manufactured In: United States
Units Affected: 224,770 tubes/connectors
Distributed To: North Dakota, New York, Virginia, West Virginia, New Jersey, Tennessee, Oklahoma, Georgia, Ohio, Minnesota, Arizona, Wisconsin, Illinois, Massachusetts, Maryland, Missouri, Arkansas, Mississippi, South Carolina, Hawaii, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.