Henry Schein Universal Tray Recall for Incomplete Sealing
Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in 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: FDA Class II medical device recall involving a manufacturing defect (incomplete sealing) that compromises product sterility. The defect creates a risk of harm in surgical procedures, and no illnesses or injuries have been reported to date.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare has recalled 675 units of the Henry Schein Universal Tray (Item No. 570-2787), which is used in medical and surgical procedures. The product was distributed nationwide in the United States and to Canada.
During manufacturing, the outer bag of affected trays may have been incompletely sealed. An incomplete seal may result in a breach of the tray's sterility, potentially exposing the contents to contamination.
Healthcare facilities that received affected trays should check product serial/lot number 22262491981 and UDI codes (case: H65857027871; kit: M75257027870) to identify affected units. Facilities should contact Stradis Medical to report receipt of recalled product and obtain instructions for return or replacement.
The recalled product
- Product
- HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Tray
- Affected units
- 675
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) H65857027871
- UDI/DI (kit)M75257027870
- Serial/Lot Numbers: 22262491981
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
- HighHenry Shein Sterile Gloves Recalled for Potential Sterility Breach
FDA (Devices) · 2023-01-18
- HighStradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
FDA (Devices) · 2023-01-18
- SevereCustomed Universal Drainage Tray Recalled Due to Compromised Sterility
FDA (Devices) · 2014-12-10
- HighCentral Line Insertion Trays Recalled for Potential Sterility Breaches
FDA (Devices) · 2023-01-18