3M Durapore Surgical Tape incorrectly labeled with extended shelf life
Select lots of 3M Durapore Surgical Tape (Catalog Number 1538-118) were labeled with a 5-year shelf life when the actual shelf life is 3 years. The recall affects over 3.5 million rolls distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall addressing shelf-life mislabeling on a medical device. No illnesses, injuries, or clinical failures have been reported. Per the rubric, labeling errors without reported harm fall under 'Minor labeling errors.'
Plain-English summary
3M Company is recalling select lots of 3M Durapore Surgical Tape, Catalog Number 1538-118. These lots were incorrectly labeled with a shelf life of 5 years, rather than the actual 3-year shelf life.
The incorrect labeling could result in use of the product beyond its actual expiration date. Surgical tape that has exceeded its actual shelf life may have compromised adhesive properties or diminished sterility, potentially affecting clinical performance.
Approximately 3,515,200 rolls have been distributed worldwide, including in the U.S. states of Texas, New York, New Hampshire, Arizona, North Carolina, California, Illinois, Georgia, Virginia, Maryland, and Florida, as well as Canada.
The specific lot codes affected by this recall have been identified. Healthcare facilities should verify their inventory against the lot-code list provided by 3M.
The recalled product
- Product
- 3M Durapore Surgical Tape, Catalog Number 1538-118
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 50707387793208
- Lot Codes: 33DER3
- 33DTMA
- 33DTPN
- 33EDDE
- 33ETFA
- 33ETHX
- 33FDHA
- 33FDYN
- 33FE9D
- 33FEY6
- 33FTLA
- 33FW6E
- 33FWPC
- 33JE7T
- 33JEFK
- 33JENC
- 33JYPX
- 33JYW5
- 33K3EJ
Distribution
Distributed nationwide across the United States.
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