Surgical Procedure Tray Recall Due to Incomplete Packaging Seal
Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses 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: FDA Class II recall with a theoretical hazard—sterility breach in surgical equipment—but no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Stradis Healthcare is recalling oral surgery procedure trays due to a manufacturing defect that may result in an incompletely sealed outer bag. This incomplete seal could compromise the sterility of the surgical kit. No illnesses or injuries have been reported to date.
Healthcare facilities and practitioners who have received these kits should discontinue use. The affected product is the STRADIS HEALTHCARE Surg Pk (Item No. 40714IES), with affected lot numbers 22229490633, distributed nationwide in the United States and Canada. A total of 18 units are subject to this recall.
For more information or instructions on returning affected kits, contact Stradis Healthcare. The FDA classified this as a Class II recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, 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 (4)
- UDI/DI (case) M75240714IES1
- UDI/DI (kit)M75240714IES0
- Serial/Lot Numbers: 22229490633
- 22229490633
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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