Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals
Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 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 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 a risk-of-harm medical device recall with no reported illnesses or injuries. A potential breach in sterility of surgical procedure trays poses significant risk, meeting the rubric criterion for High severity.
Plain-English summary
Stradis Medical, LLC is recalling STRADIS HEALTHCARE PROBE COVER W/GEL PACK (Item No. 525-071) general surgery trays.
During manufacturing, certain conditions resulted in incomplete sealing of the outer bag, which may result in a breach in the sterility of the kit.
150 units were distributed nationwide in the United States and Canada. The recall includes items with Serial/Lot Number 22252491061, UDI/DI (case) M7525250711, and UDI/DI (kit) M7525250710.
The recalled product
- Product
- STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 150
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) M7525250711
- UDI/DI (kit)M7525250710
- Serial/Lot Numbers: 22252491061
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.
See all 78 products in this recall →Related recalls
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