Medical Trays Recalled for Potentially Compromised Sterility from Incomplete Sealing
Stradis Medical is recalling 800 units of HENRY SCHEIN Vein Clinics 1 surgical trays because the outer bag may be incompletely sealed, potentially compromising sterility. No infections have been reported.
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 recall for a manufacturing defect affecting a critical product attribute (sterility) used in invasive surgical procedures. No hospitalizations or reported illnesses, but sterility compromise represents a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Stradis Medical, LLC is recalling approximately 800 units of HENRY SCHEIN Vein Clinics 1 (Item No. 570-1426) surgical procedure trays and kits due to a manufacturing defect.
During manufacturing, the outer bag of the trays may be incompletely sealed. This incomplete seal may result in a breach of the sterility assurance of the kit, which is essential for safe use in surgical procedures.
The affected product was distributed nationwide in the United States and Canada. The recall affects trays with Lot/Serial Number 22257490682. To date, no infections or illnesses related to this defect have been reported.
Patients and healthcare providers who have received these trays should contact their healthcare facility or manufacturer for information about product replacement or return.
The recalled product
- Product
- HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 800
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) H65857014261
- UDI/DI (kit)M75257014260
- Serial/Lot Numbers: 22257490682
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 · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighPHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18
- HighStradis Healthcare Foley Catheter Insertion Tray Recalled for Sterility Breach Risk
FDA (Devices) · 2023-01-18
- HighStradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
FDA (Devices) · 2023-01-18
- HighSurgical Instrument Trays Recalled for Compromised Outer Bag Sterility
FDA (Devices) · 2023-02-22
- HighSterile surgical trays recalled due to packaging puncture risk
FDA (Devices) · 2023-02-15
- SevereMedline Laceration Trays Recalled Due to Sterility Defect
FDA (Devices) · 2024-03-06