Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.
What this means for you
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 of a medical device with potential for sterility compromise in surgical procedure trays. Although no illnesses or injuries have been reported and the hazard is theoretical, the risk of harm from compromised sterility in surgical kits meets the threshold for High severity.
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling 400 units of STRADIS HEALTHCARE Vein RF Pack surgical trays (Item No. 682-1942NL1) due to manufacturing defects that may result in incompletely sealed outer bags.
The incomplete seal may result in a breach of the kit's sterility. Affected units with lot number 22251491808 were distributed nationwide in the United States and Canada.
Healthcare facilities that have received affected units should stop using them immediately and contact Stradis Healthcare for replacement units or return instructions. Users should verify lot numbers against the recall notice. No illnesses or injuries have been reported to date.
The recalled product
- Product
- STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- incomplete-seal
- sterility-breach
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) M7526821942NL11
- UDI/DI (kit)M7526821942NL10
- Serial/Lot Numbers: 22251491808
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03