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Lower risk Medical device recall · FDA · Published February 20, 2024

3M Tube Securement Devices: Missing Film Layer Risk

3M recalls two sterile tube securement devices due to potential missing top film layer or incorrect shape in some lots. Affected products have specific lot numbers and expiration dates.

🇺🇸 FDA recall #Z-1475-2024Medical device3M ›
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Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave, Bldg 275-5w-06 · Saint Paul, MN 55144-0001
✎ GovInfoNow plain-language explainer

3M is recalling two types of sterile tube securement devices because some units may have a missing top film layer or incorrect shape. This could lead to the device not staying securely in place, potentially causing tubes to move or become dislodged. Read more at govinfonow.com/recall/56137-3m-tube-securement-devices-missing-film-layer-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56137-3m-tube-securement-devices-missing-film-layer-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1475-2024

Cite this page

“3M Tube Securement Devices: Missing Film Layer Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56137-3m-tube-securement-devices-missing-film-layer-risk. Based on FDA recall #Z-1475-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1475-2024%22&limit=1).

The FDA announced on Feb. 20, 2024, that 3M Company - Health Care Business is voluntarily recalling 3M Tube Securement Devices due to manufacturing nonconformities. The hazard involves missing top film layers or incorrect shapes caused by excess material.

How to tell if you have it

  • 3M Tube Securement Device, Small, REF 1500U
  • 3M Tube Securement Device, Large, REF 1501U
  • Lot numbers: 33TNNN, 33TNMH, 33KNWC, 33KNJD, 33KND8 (REF 1500U)
  • Lot numbers: 33TNH3, 33TNDC, 33KTDY, 33KWM3, 33KTWT, 33KWHE, 33KTLA, 33KTFP, 33KT9M, 33KP6M (REF 1501U)

The hazard

Manufacturing nonconformities include the top film layer being partially or completely missing. Some devices may exhibit an incorrect shape due to excess material not being removed from the product liner.

Context

GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2015-08-06. Other recent recalls of similar products include 3M Clarity Precision Grip Attachments (2024-11-22), 3M Tegaderm CHG Dressing (2024-08-14), and 3M Durapore Surgical Tape (2024-03-20). Other recent recalls of similar products include Rocket 12Fg Seldinger Catheter Safety Guard (2025-11-07), Rocket 18Fg Seldinger Catheter with Safety Guard (2025-11-07), and Canon Vantage Galan 3T Medical Device (2025-10-16).

How to tell if you have this one

Check for the product name, size (Small: 1.7 in x 2.4 in; Large: 2.2 in x 3.5 in), and lot numbers listed in the recall (e.g., 33TNNN, 33TNMH, 33KNWC, etc.). The devices are sterile and packaged in pouches inside cartons.

  • Brand
    3M
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Lot Number

    Look for the lot number on the packaging, which is listed in the recall (e.g., 33TNNN, 33TNMH, etc.)

  2. Contact 3M for Details

    Reach out to 3M Customer Service for confirmation of the device and specific instructions if you have the recalled lot numbers

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 17 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MN, NC, NH, NY, OH, PA, TX, VA, and WA, including PR. The countries of Australia, Austria, Canada, China, Finland, Germany, Ireland, New…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Florida, Illinois, Indiana, Iowa, Kansas, Maryland, Minnesota, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Virginia, Washington.

Recall timeline

FDA published this recall 50 days after the firm started it.

1. Firm started the recall: Feb 20, 202412. FDA classified it Class II: Apr 3, 202423. Published in FDA’s Enforcement Report: Apr 10, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1475-2024 (February 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1475-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA