Ethicon Evicel Accessory Device Recall: US Distribution Risk
Ethicon recalls 45cm flexible tip accessory set (EVT45) distributed in US. Products labeled for outside US may have been sold here. No remedy specified in recall notice.
Recall notice
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Contact the company
What happened, in plain English
Ethicon is recalling a set of 45cm flexible tips (product code EVT45) that may have been distributed in the United States despite being labeled for international use. This recall addresses potential distribution errors rather than a safety hazard. Read more at govinfonow.com/recall/71749-ethicon-evicel-accessory-device-recall-us-distribution-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71749-ethicon-evicel-accessory-device-recall-us-distribution-risk · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1534-2018
Cite this page
“Ethicon Evicel Accessory Device Recall: US Distribution Risk.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71749-ethicon-evicel-accessory-device-recall-us-distribution-risk. Based on FDA recall #Z-1534-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2018%22&limit=1).
Why it’s dangerous
The recall indicates that products intended for international distribution may have been sold in the United States. This distribution error could lead to improper use if the product is used outside its intended market. There is no safety hazard described in the recall notice.
Who’s affected
Users of the Evicel Fibrin Sealant system who received this accessory set in the US may be affected. Medical professionals using the product for surgical applications are most at risk due to potential distribution errors.
How to tell if you have this one
Check for product code EVT45 on the accessory set. The product is labeled for distribution outside the United States but may have been sold in the US. The lot number 17-0102 is associated with this recall.
- Brand
Ethicon- Category
Medical device
What to do — step by step
Check Product Label
Look for product code EVT45 on the accessory set to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in 26 states and Puerto Rico.
FDA distribution: “The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1534-2018 (March 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1534-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.