Surgical Pain Tray Outer Bag May Not Be Properly Sealed
Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.
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 potential sterility breach of surgical procedure trays. While no illnesses or injuries are reported, the hazard represents a risk of infection from non-sterile surgical instruments during medical procedures, justifying a high severity rating.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the Henry Schein Surgical Pain Tray (Item No. 570-1482) distributed nationwide in the US and Canada. During manufacturing, certain conditions may have resulted in incomplete sealing of the outer bag of the surgical tray.
The incomplete seal may allow a breach in the sterility of the surgical tray. Sterile surgical instruments are critical to preventing infection during medical procedures. Non-sterile instruments pose a significant risk to patient safety.
Healthcare providers and facilities with these trays should stop using them immediately and contact their supplier for replacement or proper disposal instructions. Affected units are identified by UDI/DI case number M75257014821, UDI/DI kit number M75257014820, and Lot/Serial Number 22235489736.
The recalled product
- Product
- HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 20
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) M75257014821
- UDI/DI (kit)M75257014820
- Serial/Lot Numbers: 22235489736
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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