Agency classClass IIOur severity:High FDA (Devices)·Z-0719-2020·Announced 2020-01-01

3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk

3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.

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 involves a risk-of-harm product (ingestion/aspiration of fibers) where injury has not yet been reported, aligning with the 'High' severity criteria for theoretical hazards without confirmed harm.

Plain-English summary

3M Company - Health Care Business is recalling 470,954 rolls of 3M Durapore Advanced Surgical Tape. The affected model numbers include 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, and 1590B-136. The recall covers all lots of the product.

The recall was initiated because long-term exposure of the tape to continuous high moisture clinical applications has not fully met 3M's performance expectations. This specific use environment may cause the tape bond to fail, preventing the tape from performing as intended. Additionally, the tape fibers may fray, which could lead to accidental ingestion or aspiration.

The product was distributed nationwide in the United States, as well as in Canada, Germany, France, Switzerland, and Denmark. No specific illnesses or injuries have been reported in the source text. Consumers and healthcare providers should stop using the affected product and follow instructions from 3M or the FDA regarding return or disposal.

The recalled product

Product: 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
Manufacturer: 3M Company - Health Care Business
Category: Medical Device — Surgical Tape
Hazard: ingestion
aspiration
product-failure
Affected units: 470,954

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 (1)

All lots

Distribution

Distributed nationwide across the United States.

Same manufacturer · 3M Company - Health Care Business

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