Genicon EZEE Retrieval Recall: Plastic Handle Breaks Off During Use
Genicon recalls sterile EZEE Retrieval devices due to plastic handle breaking off, which can prevent proper removal. Affected units have specific catalog and lot numbers.
Use caution until it’s fixed
Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use.
Contact the company
What happened, in plain English
Genicon is recalling sterile EZEE Retrieval devices because the plastic handle can break off during use, making it difficult to remove the device properly. This could lead to improper removal and potential complications for patients. Read more at govinfonow.com/recall/73395-genicon-ezee-retrieval-recall-plastic-handle-breaks-off-during-use.
Source Summary by GovInfoNow · govinfonow.com/recall/73395-genicon-ezee-retrieval-recall-plastic-handle-breaks-off-during-use · Updated September 20, 2026 · FDA enforcement record: FDA #Z-1076-2018
Cite this page
“Genicon EZEE Retrieval Recall: Plastic Handle Breaks Off During Use.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73395-genicon-ezee-retrieval-recall-plastic-handle-breaks-off-during-use. Based on FDA recall #Z-1076-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2018%22&limit=1).
Why it’s dangerous
The plastic handle can break off during use, which prevents the device from being removed properly as instructed. This could lead to complications if the device remains in place longer than intended.
Who’s affected
Patients using this sterile medical device for procedures under a doctor's prescription. Those with the specific catalog and lot numbers listed are most at risk.
How to tell if you have this one
Check the catalog number (550-000-000) and lot numbers (I8095/2017-11-08, I8162-2018-01-09, I8162/2020-01-09) on the device packaging or label.
- Brand
Genicon- Category
Medical device
What to do — step by step
Check Device for Handle Breakage
Inspect the device to see if the plastic handle is broken off. If so, stop using it immediately.
Contact Manufacturer for Details
Reach out to Genicon, Inc. for specific instructions on how to proceed with the recall.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “Distributed domestically to FL, IL, MI, TN, UT. Distributed internationally to Dominican Republic, Ireland, Denmark, Spain, Switzerland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Illinois, Michigan, Tennessee, Utah.
Recall timeline
FDA terminated this recall 2.8 years 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-1076-2018 (July 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1076-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 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.