LeMaitre Vascular LeverEdge Contrast Injector Recall: Particulate Risk in Packaging
LeMaitre Vascular recalls 35cc syringes with ISO 594 female luer lock due to potential particulate contamination in packaging foam that could affect sterile procedures.
Lower-risk recall
The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
Contact the company
What happened, in plain English
LeMaitre Vascular is recalling 35 cc syringes with ISO 594 female luer locks because packaging foam may contain particles that could contaminate sterile medical fields during use. This risk could lead to infections or complications during angiographic procedures. Read more at govinfonow.com/recall/62856-lemaitre-vascular-leveredge-contrast-injector-recall-particulate-risk-in-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/62856-lemaitre-vascular-leveredge-contrast-injector-recall-particulate-risk-in-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1529-2021
Cite this page
“LeMaitre Vascular LeverEdge Contrast Injector Recall: Particulate Risk in Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62856-lemaitre-vascular-leveredge-contrast-injector-recall-particulate-risk-in-packaging. Based on FDA recall #Z-1529-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1529-2021%22&limit=1).
Why it’s dangerous
Packaging foam in the syringes may contain particles that could contaminate the sterile field during medical procedures. This contamination might lead to infections or complications if the syringes are used without proper cleaning.
Who’s affected
Healthcare professionals using these syringes for angiographic procedures are most at risk. Patients receiving contrast media injections during these procedures may also be affected.
How to tell if you have this one
Check for syringes with the catalog number 4100-00 and lots LCI1091 through LCI1099. These were sold for angiographic procedures using contrast media.
- Brand
LeMaitre Vascular- Category
Medical device
What to do — step by step
Check Product Lot
Identify the lot number on the syringe packaging to determine if it is in the affected range (LCI1091 to LCI1099).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Missouri, New York, Ohio, Tennessee, Texas.
Recall timeline
FDA terminated this recall 21 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-1529-2021 (April 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1529-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.