Oral Surgery Trays Recalled for Incomplete Sealing of Sterility Bags
Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.
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 affecting sterile surgical instruments. While no illnesses or injuries have been reported, the product presents a risk of harm—incomplete sealing of surgical trays could result in non-sterile instruments being used in surgery, potentially leading to infection. The hazard is documented but injury has not yet been reported, placing this at the High severity level.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE oral surgery trays (Item No. 40551TMS). The recall affects 6 units, distributed to the United States and Canada, identified by lot number 22230489112.
During manufacturing, certain trays underwent conditions that resulted in incomplete sealing of the outer bag. An incompletely sealed bag may breach the sterility of the surgical instruments, potentially compromising the safety of surgical use.
Healthcare facilities, surgical centers, and healthcare providers who received this product should stop using the affected trays immediately and contact the manufacturer, Stradis Medical, LLC, for return instructions and replacements.
The recalled product
- Product
- STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- 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) M75240551TMS1
- UDI/DI (kit)M75240551TMS0
- Serial/Lot Numbers: 22230489112
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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