OMNI K1 Broach Handle Recalled Due to Loose Inner Pin Risk
OMNIlife science Inc. is recalling seven OMNI K1 Broach Handles because the inner pin may become loose and fall out.
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 involves a medical device with a mechanical defect that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
OMNIlife science Inc. is recalling seven units of the OMNI K1 Broach Handle, Product Code HS-10054. The recall is due to a potential defect where the inner pin of the handle may become loose and fall out.
The affected units, identified by Lot Number MM0118, were distributed to the following US states: California, Georgia, South Carolina, and Utah.
Consumers who possess this product should stop using it immediately and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- OMNI K1 Broach Handle, Product Code HS-10054
- Manufacturer
- OMNIlife science Inc.
- Hazard
- Affected units
- 7
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 (1)
- Lot Number MM0118
Distribution
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