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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

3M Company - Health Care Business: Tube Securement Device Recalled for Manufacturing Defects

Agency Publication Date: April 3, 2024
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Summary

3M Company is recalling 265,435 units of its sterile Tube Securement Devices (Small and Large) due to manufacturing errors where the top film layer may be missing or the device may be incorrectly shaped. These devices are used to secure medical tubing to patients and were distributed nationwide across 17 states and several international countries. Because the devices may have excess material or missing components, they may not function as intended. Consumers should contact their healthcare provider or the manufacturer for guidance and to determine if their specific devices are impacted.

Risk

A missing film layer or incorrect device shape can prevent the product from properly securing medical tubes, potentially leading to accidental tube displacement or detachment. There is also a risk of skin irritation or compromised sterility if the device's protective layers are not intact.

What You Should Do

  1. Check your supply for 3M Tube Securement Device, Small (REF 1500U, SKU 70-2011-8908-4, UDI-DI 30707387792405) with the following lot numbers and expiration dates: 33TNNN (Exp. 2025-11-09), 33TNMH (Exp. 2025-11-08), 33KNWC (Exp. 2024-06-02), 33KNJD (Exp. 2024-06-01), or 33KND8 (Exp. 2024-05-31).
  2. Check your supply for 3M Tube Securement Device, Large (REF 1501U, SKU 70-2011-8924-1, UDI-DI 30707387792399) with the following lot numbers and expiration dates: 33TNH3 (Exp. 2025-11-08), 33TNDC (Exp. 2025-11-07), 33KTDY (Exp. 2024-06-11), 33KWM3 (Exp. 2024-06-15), 33KTWT (Exp. 2024-06-13), 33KWHE (Exp. 2024-06-14), 33KTLA (Exp. 2024-06-12), 33KTFP (Exp. 2024-06-11), 33KT9M (Exp. 2024-06-10), or 33KP6M (Exp. 2024-06-03).
  3. If you identify affected lots, do not use the device and contact your healthcare provider or 3M Company directly for further instructions and potential product return details.
  4. For additional questions regarding this recall, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile
Model / REF:
REF 1500U
SKU 70-2011-8908-4
UDI-DI 30707387792405
Lot Numbers:
33TNNN (Exp. 2025-11-09)
33TNMH (Exp. 2025-11-08)
33KNWC (Exp. 2024-06-02)
33KNJD (Exp. 2024-06-01)
33KND8 (Exp. 2024-05-31)
Date Ranges: 2025-11-09, 2025-11-08, 2024-06-02, 2024-06-01, 2024-05-31
Product: 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile
Model / REF:
REF 1501U
SKU 70-2011-8924-1
UDI-DI 30707387792399
Lot Numbers:
33TNH3 (Exp. 2025-11-08)
33TNDC (Exp. 2025-11-07)
33KTDY (Exp. 2024-06-11)
33KWM3 (Exp. 2024-06-15)
33KTWT (Exp. 2024-06-13)
33KWHE (Exp. 2024-06-14)
33KTLA (Exp. 2024-06-12)
33KTFP (Exp. 2024-06-11)
33KT9M (Exp. 2024-06-10)
33KP6M (Exp. 2024-06-03)
Date Ranges: 2025-11-08, 2025-11-07, 2024-06-11, 2024-06-15, 2024-06-13, 2024-06-14, 2024-06-12, 2024-06-11, 2024-06-10, 2024-06-03

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94039
Status: Active
Manufacturer: 3M Company - Health Care Business
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: United States
Units Affected: 265,435 eaches
Distributed To: California, Colorado, Florida, Iowa, Illinois, Indiana, Kansas, Maryland, Minnesota, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Texas, Virginia, Washington, Puerto Rico

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.