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.
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 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
- Hazard
- sterility-breach
- contamination-risk
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.
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