Stradis Healthcare Oral Surgery Trays Recalled Due to Incomplete Sealing
Stradis Healthcare is recalling oral surgery trays due to incomplete outer bag sealing that may compromise the sterility of the surgical kit.
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 an FDA Class II recall for a surgical medical device where the potential loss of sterility assurance presents a risk of harm in clinical use, though no illnesses or injuries have been reported. The incomplete outer bag sealing poses a theoretical but significant risk of surgical site complications.
Plain-English summary
Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling STRADIS HEALTHCARE pack Item No.40788SMS oral surgery trays distributed nationwide in the United States and Canada. The recall stems from certain manufacturing conditions that resulted in incompletely sealed outer bags on the surgical trays, which may compromise the sterility of the surgical kit—a critical concern for safe oral surgery procedures.
Affected units bear UDI/DI code M75240788SMS1 (case) or M75240788SMS0 (kit), with Serial/Lot Number 22234489435. Healthcare facilities and surgeons who have received these trays should verify they do not have affected product in their inventory.
No illnesses or injuries related to this recall have been reported. For more information or questions about whether your trays are affected, consult the FDA recall notice.
The recalled product
- Product
- STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- Affected units
- 6
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) M75240788SMS1
- UDI/DI (kit)M75240788SMS0
- Serial/Lot Numbers: 22234489435
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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