FDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
The FDA is recalling sterile Devon Light Gloves because splits or holes compromise their sterility. The recall covers 26,108,946 units distributed worldwide.
What this means for you
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 a medical device, which presents a risk of harm, but the source text does not report specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Devon Light Gloves, Sterile-Single Units, manufactured by Covidien LLC. These products are disposable, sterile, single-use covers designed for compatible surgical light handles. The recall is being conducted because the gloves contain splits or holes that compromise their sterility.
The recall involves 26,108,946 units. The affected products are identified by lot numbers beginning with 508xxxx or lower. The specific catalog numbers included in the recall are 31140208 (3611 LIGHT GLOVE), 31140216 (3613 LIGHT GLOVE), and 31140257 (3612 LIGHT GLOVE).
The affected units were distributed nationwide in the United States, including the Virgin Islands, as well as in Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Finland, France, Germany, the Netherlands, Sweden, Ireland, Israel, Spain, Italy, Jordan, Kenya, Kuwait, the United Kingdom, Lebanon, Liechtenstein, Luxembourg, Monaco, South Africa, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovenia, Switzerland, Turkey, and the UAE. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 26,108,946
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
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.
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