STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach
Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.
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: This is a Class II medical device recall without reported illnesses or injuries. The hazard is a potential sterility breach from incomplete sealing, creating a contamination risk during surgical procedures. This meets the rubric criterion for a risk-of-harm product without reported injury.
Plain-English summary
Stradis Medical, LLC is recalling STRADIS HEALTHCARE surgical procedure trays, Item No. 40510TWS, used in oral surgery. These trays are distributed throughout the US and Canada.
During manufacturing, these trays underwent certain conditions that may result in the outer bag being incompletely sealed. An incomplete seal may compromise the sterility of the kit, creating a potential contamination risk during oral surgical procedures.
The affected product is identified by UDI/DI case code M75240510TWS1 and kit code M75240510TWS0, with Lot Number 22236490637. Eighteen units have been distributed. Consumers and healthcare facilities with this product should verify their lot numbers to determine if they are affected.
The recalled product
- Product
- STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 18
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 (3)
- UDI/DI (case) M75240510TWS1
- UDI/DI (kit)M75240510TWS0
- Serial/Lot Numbers: 22236490637
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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