Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility
Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.
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 involving a manufacturing defect that may compromise the sterility of surgical procedure trays. The potential for contamination or infection from non-sterile surgical instruments represents a material risk of harm.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling STRADIS HEALTHCARE SURGE-O-VAC .125" GREEN surgical procedure trays (Item No. SS077225). This recall involves 75 units with Lot Number 22255490439, distributed nationwide in the United States and Canada.
Medical and surgical procedure trays underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed. An incompletely sealed outer bag may result in a breach in the sterility of the kit, which is essential for safe use in surgical and medical procedures.
The recalled product
- Product
- STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 75
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) M752SS0772251
- UDI/DI (kit)M752SS0772251
- Serial/Lot Numbers: 22255490439
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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