Ethicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error
Ethicon is recalling Evicel Accessory Device 45 cm Flexible Tips because products labeled for foreign distribution may have been distributed in the US.
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 does not report any illnesses, injuries, or specific safety hazards, indicating a low-risk contamination or labeling/distribution issue.
Plain-English summary
Ethicon, Inc. is recalling the Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. These accessory tips are intended for use only with the EVICEL Fibrin Sealant (Human) Application Device. The recall involves 738 devices, packaged as 246 boxes of 3, from Lot 17-0102.
The recall was initiated because products labeled for distribution outside the United States may have been distributed to customers in the United States. The devices were distributed to customers in Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Pennsylvania, Tennessee, Texas, Washington, Wisconsin, West Virginia, and Puerto Rico.
Healthcare providers and patients should stop using the recalled accessory tips and contact Ethicon, Inc. for further instructions or a replacement.
The recalled product
- Product
- Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
- Manufacturer
- Ethicon, Inc.
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 17-0102
Distribution
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