FDA Adds Instructions for Use to Covidien Devon Light Glove Recall
The FDA is adding instructions to inspect the barrier integrity of the Covidien Devon Light Glove after application. This affects sterile surgical kits distributed in the US and abroad.
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: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text indicates a procedural update (adding instructions for use) rather than a reported injury or a high-risk pathogen, fitting the 'Moderate' criteria for voluntary precautionary or labeling/instruction updates.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for the Covidien Devon Light Glove, a disposable, sterile, single-use cover for compatible surgical light handles. The product is packaged in various sterile surgical kits manufactured by Covidien LLC. The recall involves 13,786,893 units distributed in the United States and worldwide, including Canada and numerous European and Middle Eastern countries.
The reason for the recall is the addition of new Instructions for Use. The updated guidance requires that after application, the Light Glove must be inspected for barrier integrity. This procedural update is intended to ensure the device functions as a proper sterile barrier during surgical procedures.
Healthcare facilities and consumers who have these specific surgical kits should review the updated instructions. The affected kits include a wide range of item numbers, such as the 7335-SMC Delivery Kit, 7519-DHCG Surgi-Start Kit, and various Standard Mini-Kits. Users should ensure they are following the new requirement to inspect the glove for barrier integrity after it has been applied to the surgical light handle.
The recalled product
- Product
- Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for compatible surgical light handles
- Manufacturer
- Covidien LLC
- Affected units
- 13,786,893
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 (2)
- SURGI START 31145363 7496-88 STANDARD
- MINI-PLUS KIT 31145397 7497-8 STANDARD MINI PLUS KIT 31145413 7497-88 STANDARD
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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