FDAMarch 30, 2021device
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 a scalpel. Model:...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
What to do
FDA enforcement status: Terminated
Brands named
omnia srlomnia
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- FDA.155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, 190g 6.70 oz - 20 packages per case LOT: 2523000012 - BEST BEFORE: 10/17/2026 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- FDAREF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile2024-09-24
- FDATiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.2024-07-15
- FDATiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.2024-07-15
- FDAEmbrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S2023-07-13
- FDAHerniatome, 17G x 9cm, Cervical Type, Model Number 50917492021-05-17
- FDAHerniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 50917152021-05-17
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