Genicon EZEE Retrieval recalled due to plastic handle breaking off shaft
Genicon, Inc. is recalling 2,967 units of GENICON EZEE Retrieval because the plastic handle may break off the shaft, inhibiting proper removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a mechanical failure that inhibits proper removal of a medical device, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Genicon, Inc. is recalling 2,967 units of GENICON EZEE Retrieval, sterile, Rx only. The recall was initiated because the plastic handle is breaking off of the shaft, which inhibits proper removal per the Instructions for Use.
The affected product is identified by Catalog No. 550-000-000 and UDI 00877972005223. Specific lot numbers include I8095/2017-11-08, I8162-2018-01-09, and I8162/2020-01-09. The product was distributed domestically to Florida, Illinois, Michigan, Tennessee, and Utah, as well as internationally to the Dominican Republic, Ireland, Denmark, Spain, Switzerland, and the United Kingdom.
Healthcare providers and patients should stop using the affected units and contact Genicon, Inc. for further instructions or replacement.
The recalled product
- Product
- GENICON EZEE Retrieval, sterile, Rx only.
- Manufacturer
- Genicon, Inc.
- Affected units
- 2,967
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog No. 550-000-000
- Lot No. I8095/2017-11-08
- I8162-2018-01-09
- I8162/2020-01-09
- UDI: 00877972005223.
Distribution
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