Stradis Healthcare Medical and Surgical Trays Recalled for Incomplete Bag Sealing
Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were 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 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 medical device recall with potential sterility breach. No illnesses or injuries reported; the hazard is theoretical, meeting the rubric criterion for risk-of-harm products with no yet-reported injury.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE Lipo medical and surgical procedure trays and kits. The recalled products underwent certain manufacturing conditions that may result in incomplete sealing of the outer bag.
An incompletely sealed outer bag may result in a breach of the kit's sterility. This could compromise the integrity and safety of the medical device.
The recall affects six units (Item No. 681-254, UDI/DI case M7526812541, UDI/DI kit M7526812540, Serial/Lot 22270492010) distributed nationwide in the United States and Canada. Healthcare facilities and end users who have obtained these products should discontinue use and contact Stradis Medical for return or replacement instructions.
The recalled product
- Product
- STRADIS HEALTHCARE, Lipo, Item No.681-254,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kits
- 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) M7526812541
- UDI/DI (kit)M7526812540
- Serial/Lot Numbers: 22270492010
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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