Dental Procedure Trays Recalled for Incomplete Outer Bag Seal
STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a medical device with a manufacturing defect (incomplete seal) that could compromise product sterility. No illnesses or injuries have been reported. The hazard is theoretical—potential sterility breach—rather than confirmed contamination, placing this at Moderate severity.
Plain-English summary
STRADIS HEALTHCARE Custom Pack dental surgical procedure trays and kits are being recalled due to a manufacturing defect. The outer packaging bags may be incompletely sealed, which could result in a breach of the kit's sterility. Sterile conditions are essential for medical and surgical procedures to prevent contamination and infection.
The recall affects STRADIS HEALTHCARE Custom Pack with Item Number 41213ATCP and serial/lot number 22262491452. Approximately 12 units were distributed nationwide in the United States and Canada.
Facilities and individuals with these products should contact the manufacturer, Stradis Medical, LLC dba Stradis Healthcare, for guidance on return or replacement options.
The recalled product
- Product
- STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 12
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) M75241213ATCP1
- UDI/DI (kit)M75241213ATCP0
- Serial/Lot Numbers: 22262491452
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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