Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing
Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.
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 compromise on surgical procedure kits. Although no illnesses have been reported, the risk-of-harm from compromised sterility in surgical instruments justifies a High rating.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling 144 units of the Henry Schein Loop Recorder Pack surgical procedure trays (Item No. 570-2891, Lot No. 22252491813). The product was distributed nationwide in the United States and Canada.
The outer bag on these trays may be incompletely sealed due to the manufacturing process used. An incomplete seal can compromise the sterility of the kit, which is critical for safe use in surgical and medical procedures.
Users should immediately stop using the recalled product. Healthcare facilities and consumers with the affected lot should contact Stradis Medical for replacement or return instructions. No illnesses or injuries related to this issue have been reported to date.
The recalled product
- Product
- HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Trays
- Affected units
- 144
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) H65857028911
- UDI/DI (kit)M75257028910
- Serial/Lot Numbers: 22252491813
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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