Lower riskMedical device recall · FDA · Published June 27, 2018
Genicon EZee Specimen Retrieval Bag Recall: Multiple Use Risk
Genicon recalls disposable specimen retrieval bags that may be used for multiple specimens, risking contamination. Affected units include model 550-000-00:000 with lot I8920 from August 2020.
“Genicon EZee Specimen Retrieval Bag Recall: Multiple Use Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70720-genicon-ezee-specimen-retrieval-bag-recall-multiple-use-risk. Based on FDA recall #Z-2005-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2005-2020%22&limit=1).
The FDA announced on June 27, 2018, that Genicon, Inc. is recalling its Genicon EZee Single Use Specimen Retrieval Bags due to potential misuse for multiple specimen retrievals. The agency stated the device is packaged and sterilized for single use only.
How to tell if you have it
Brand: Genicon
Product: Genicon EZee Single Use Specimen Retrieval Bag
Model: 550-000-000
UDI: 00877972005230
Lot: I8920/2020-08-29
Quantity: 1,550 units
The hazard
The recall addresses the risk that users may employ the disposable bag for multiple specimen retrievals, contrary to its single-use designation. The FDA noted that Genicon is providing updated Instructions for Use (IFU) labeling to clarify proper usage.
Context
GovInfoNow's records show Genicon, Inc. has issued four other recalls since July 19, 2017. Other recent recalls of similar products include the Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), the Intuitive Surgical Ion Vision Probe Bag Recall (Dec. 4, 2025), and the Milestone Vacuum Bag SU Large Specimen Container Recall (March 9, 2026).
How to tell if you have this one
Check for model number 550-000-000 and lot number I8920 from August 2020. The bags are labeled as disposable and sterilized for single use only.
Brand
Genicon
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Bag Label
Look for model number 550-000-000 and lot number I8920 from August 2020 on the bag.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of IL, IN, MO,TN, and the country of Denmark.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Indiana, Missouri, Tennessee.
Recall timeline
FDA published this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2005-2020 (June 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2005-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 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.