Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Genicon, Inc.
- Reason for Recall:
- Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.
Product Codes/Lot Numbers:
Device Model 550-000-000; UDI 00877972005230; Lot I8920/2020-08-29
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2005-2020
Related Recalls
Device malfunction causing the applier to jam, and clip loading failures.
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
There is potential for the plastic optical tip to become detached from the metal shaft.