Omnia Soft Tissue Punch Recalled Due to Inadequate Sterilization
Omnia SRL is recalling dental soft tissue punches because the contract manufacturer reported inadequate sterilization processes at their facility since 2016.
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 risk of harm due to inadequate sterilization, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Omnia SRL is recalling the Omnia Soft Tissue Punch, a dental instrument used to remove circular sections of oral soft tissue during surgery. The recall affects 276,901 units distributed domestically in Alaska, Illinois, Pennsylvania, Oklahoma, Texas, Utah, New York, and California, as well as in numerous foreign countries including Australia, Canada, and various European nations.
The recall was initiated after Omnia SRL received a notification from the contract manufacturer regarding inadequate sterilization processes. These processes have been occurring at the contracted sterilizing facility since 2016. The affected products include multiple models and lots, specifically identified in the recall documentation.
Consumers and healthcare providers should stop using the affected instruments and contact Omnia SRL for instructions on return or replacement. The specific lot numbers and model codes are listed in the official recall notice.
The recalled product
- Product
- Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of…
- Manufacturer
- Omnia SRL
- Affected units
- 276,901
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 (20)
- Lot:118
- 317
- 319
- 516
- 616
- 617
- 618
- 620
- 716
- 719
- 720
- 817
- 818
- 916
- 920
- 1016
- 1018
- 1216
- 1217
- 1316
Distribution
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