Procedure Trays Recalled for Potential Sterility Breach Due to Incomplete Sealing
Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed 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: This recall is classified as High (Score 3) under FDA Class II criteria. The hazard—potential sterility breach of medical procedure trays due to incomplete sealing—represents a risk of harm to patients if contaminated instruments are used in medical procedures. However, no illnesses or injuries have been reported in the source material.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Henry Schein procedure trays (Item No. 570-2900, distributed under UDI codes H65857029001 and M75257029000). The recalled trays were distributed nationwide in the United States and in Canada.
During manufacturing, the outer bag of these procedure trays may have been incompletely sealed. An incomplete seal could result in a breach of the kit's sterility, potentially allowing contamination of the medical instruments inside.
Affected lot numbers include 22252489760. Healthcare facilities and users who have these procedure trays should discontinue use and contact Stradis Medical or Henry Schein for further guidance.
The recalled product
- Product
- HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 10
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) H65857029001
- UDI/DI (kit)M75257029000
- Serial/Lot Numbers: 22252489760
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.
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