FDA Recalls Custom Packaging for Devon Light Gloves
The FDA is recalling custom packaging for Devon Light Gloves due to added instructions for use regarding barrier integrity inspection.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text indicates the issue is related to added instructions for use rather than a reported defect causing injury or a high-risk pathogen, fitting the criteria for a moderate severity precautionary or labeling-related recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for custom packaging containing the Devon Light Glove, manufactured by Covidien LLC. The affected products include specific item numbers for Sure Set Single Basin Packs, Major Basin Packs, and Basin Packs. The recall involves 4,950 units that were distributed worldwide, including across the United States and numerous foreign countries such as Canada, the United Kingdom, and various European nations.
The reason for the recall is the addition of instructions for use that state: "After application, inspect the Light Glove for barrier integrity." This update addresses the need for users to verify the integrity of the sterile barrier after the product is applied to compatible surgical light handles. The product is described as a disposable, sterile, single-use cover.
Healthcare facilities and distributors should stop using the affected custom packaging and follow the instructions provided by the recalling firm, Covidien LLC. Users are advised to inspect the Light Glove for barrier integrity after application as per the new instructions.
The recalled product
- Product
- Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN PACK 400383006 MAJOR BASIN PACK…
- Manufacturer
- Covidien LLC
- Affected units
- 4,950
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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Similar recalls
- HighFDA Recalls Sterile Single Basin Kits with Compromised Gloves
FDA (Devices) · 2015-07-29
- HighFDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
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