The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1892-2013·Announced 2013-08-14

ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where the inability to confirm sterility presents a potential infection risk, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips (30 strips, 1/4 in. x 4 in., sterile, latex-free) due to the inability to confirm sterility. The recall was initiated by Aspen Surgical Products, Inc.

The affected products are identified by UPC # 096295114706 and specific ASO Packaging Lot numbers: 114870, 321860, 386990, 474650, 223251, 237641, 328481, 228682, and 266542. A total of 2,689,560 pouches (2 cards per pouch) were distributed nationwide, including in Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin.

Consumers should stop using the recalled products and contact ASO, LLC for further instructions or a refund.

The recalled product

Product
Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
Manufacturer
ASO, LLC
Category
Medical Device — Wound Closure
Hazard

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 (9)

  • ASO Packaging Lot #s: 114870
  • 321860
  • 386990
  • 474650
  • 223251
  • 237641
  • 328481
  • 228682
  • and 266542

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 9 recalled by ASO, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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