Stradis Medical gynecological surgical kit recalled due to potential sterility breach
Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and 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 FDA Class II recall involves a surgical kit with potential sterility breach but no reported illnesses or injuries. As a medical device used in sterile procedures where a sterility breach poses direct risk of harm, it qualifies as High severity under the risk-of-harm criterion.
Plain-English summary
Stradis Medical, LLC is recalling the Henry Schein GYN Pack (Item No. 570-2625), a surgical tray kit used in gynecological and medical procedures. The recall affects kits with lot number 22230491067, distributed nationwide in the United States and Canada.
During manufacturing, the outer bag of these kits may have been incompletely sealed. This incomplete seal may result in a breach of the kit's sterility, potentially compromising the sterile field required for safe medical procedures.
No illnesses or injuries related to this recall have been reported to the FDA.
If you have received one of these kits, do not use it. Contact Stradis Medical or your healthcare facility's equipment manager for instructions on return or replacement.
The recalled product
- Product
- HENRY SCHEIN, GYN PACK, Item No.570-2625
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Kit
- 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) H65857026251
- UDI/DI (kit)M75257026250
- Serial/Lot Numbers: 22230491067
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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