Agency classClass IIOur severity:High FDA (Devices)·Z-2117-2015·Announced 2015-07-29

FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes

The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.

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. The hazard involves compromised sterility in medical gloves, which poses a risk of infection or exposure to contaminants, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Devon Light Gloves, manufactured by Covidien LLC. The recall is due to the presence of splits or holes in the gloves, which compromises their sterility. The affected product is the NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile, with catalog number 571711.

The recall includes lots with numbers beginning 508xxxx or lower. These gloves were distributed worldwide, including in the United States (nationwide, including the Virgin Islands), Canada, Australia, New Zealand, and numerous countries in Europe, the Middle East, Africa, and Asia. The source text does not specify the exact number of units recalled or the specific dates of distribution.

Consumers and healthcare facilities should stop using the affected gloves and contact the manufacturer or their supplier for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Manufacturer: Covidien LLC
Category: Medical Device — Gloves
Hazard: sterility-compromise
physical-defect

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)

Lot number begins 508xxxx or lower

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Covidien 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 14 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility compromise