Stradis Healthcare Endo Pack Surgical Trays Recalled for Incomplete Seal
Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.
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: Class II FDA medical device recall for sterile surgical trays. An incompletely sealed outer bag may compromise the kit's sterility and create contamination risk. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High (Score 3) criterion.
Plain-English summary
Stradis Healthcare is recalling Endo Pack medical procedure trays, Item No. 682-509, due to a manufacturing defect. The outer bag of affected units may be incompletely sealed, which may result in a breach of the sterility of the kit.
The recalled product was distributed nationwide in the United States and in Canada. The affected lot number is 22256490827. The product can be identified using UDI/DI case code M7526825091 and UDI/DI kit code M7526825090.
The recalled product
- Product
- STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 25
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) M7526825091
- UDI/DI (kit)M7526825090
- Serial/Lot Numbers: 22256490827
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
Same manufacturer · Stradis Medical, LLC dba Stradis Healthcare
See all →- HighStradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighGeneral Surgery Procedure Kit Recalled for Sterility Concerns
FDA (Devices) · 2022-12-21
- HighStradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Trays Recalled for Potential Sterility Breach
FDA (Devices) · 2022-12-21
- HighSurgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
FDA (Devices) · 2022-12-21
Same hazard · seal defect
See all →- HighMedical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect
FDA (Devices) · 2026-08-12
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- HighMedline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
FDA (Devices) · 2026-03-04