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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

3M Company - Health Care Business: Durapore Surgical Tape Recalled for Incorrect Shelf Life Labeling

Agency Publication Date: April 24, 2024
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Summary

3M Company is recalling 3,515,200 rolls of 3M Durapore Surgical Tape (Catalog Number 1538-118) because select lots were incorrectly labeled with a 5-year shelf life instead of the correct 3-year shelf life. Using the tape beyond its actual 3-year expiration date may result in the product not performing as expected. The affected rolls were distributed nationwide in the United States and across Canada.

Risk

The tape was labeled with an expiration date two years longer than its validated performance period, which could lead to reduced adhesive strength or material degradation if used after the actual 3-year limit. No specific injuries have been reported, but compromised tape could fail to properly secure medical dressings or devices.

What You Should Do

  1. Check your supply of 3M Durapore Surgical Tape for Catalog Number 1538-118 and UDI/DI 50707387793208.
  2. Identify if your product belongs to one of the following affected Lot Codes: 33DER3, 33DTMA, 33DTPN, 33EDDE, 33ETFA, 33ETHX, 33FDHA, 33FDYN, 33FE9D, 33FEY6, 33FTLA, 33FW6E, 33FWPC, 33JE7T, 33JEFK, 33JENC, 33JYPX, 33JYW5, 33K3EJ, 33KPWT, 33KT6R, 33KT8F, 33LJWC, 33LK5M, 33LLEY, 33LLPT, 33LM6R, 33LMET, 33LMX3, 33N56W, 33N5K4, 33N5TC, 33NF36, 33NF6A, 33NY98, 33NYP9, 33P37P, 33PKLN, 33PL6J, 33PMFA, 33R35M, 33R3P6, 33RMNF, 33RNP4, 33TL39, 33TL8F, 33TLF4, 33TN55, 33WEA8, 33WEHJ, 33WERX, 33WF5P, or 33WFD5.
  3. If you possess tape from these lots, verify the manufacturing date and ensure the product is not used more than 3 years past that date, regardless of the 5-year expiration printed on the label.
  4. Contact your healthcare provider or 3M Company at 1-888-364-3577 for further instructions regarding affected product and potential replacement or refund options.
  5. For additional information, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: 3M Durapore Surgical Tape, Catalog Number 1538-118
Model / REF:
1538-118
UPC Codes:
50707387793208
Lot Numbers (53):
33DER3
33DTMA
33DTPN
33EDDE
33ETFA
33ETHX
33FDHA
33FDYN
33FE9D
33FEY6
33FTLA
33FW6E
33FWPC
33JE7T
33JEFK
33JENC
33JYPX
33JYW5
33K3EJ
33KPWT
33KT6R
33KT8F
33LJWC
33LK5M
33LLEY
33LLPT
33LM6R
33LMET
33LMX3
33N56W
33N5K4
33N5TC
33NF36
33NF6A
33NY98
33NYP9
33P37P
33PKLN
33PL6J
33PMFA
33R35M
33R3P6
33RMNF
33RNP4
33TL39
33TL8F
33TLF4
33TN55
33WEA8
33WEHJ

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94259
Status: Active
Manufacturer: 3M Company - Health Care Business
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 3,515,200 rolls
Distributed To: Texas, New York, New Hampshire, Arizona, North Carolina, California, Illinois, Georgia, Virginia, Maryland, Florida

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.