Breast Augmentation Trays Recalled Due to Incomplete Packaging Seal
Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and 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: This is a Class II recall of a high-risk surgical device. The manufacturing defect (incomplete seal) creates a real risk of sterility breach on a surgical instrument used in invasive procedures. No illnesses or injuries have been reported, which limits the score to 3 per the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling Henry Schein breast augmentation trays (Item No. 570-0611) due to a manufacturing defect. The outer bag of the affected trays may be incompletely sealed, which could result in a breach of the kit's sterility.
The recall affects 10 units distributed nationwide in the United States and Canada. Affected kits can be identified by UDI/DI case code H65857006111, UDI/DI kit code M75257006110, and lot/serial number 22257490683.
Healthcare facilities and users should stop using affected trays and contact Stradis Medical or Henry Schein for replacement. Use of a sterile surgical tray with a compromised seal may expose patients to contamination risk during breast augmentation procedures.
The recalled product
- Product
- HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Category
- Medical Device — Surgical Trays
- Hazard
- sterility-breach
- incomplete-seal
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) H65857006111
- UDI/DI (kit)M75257006110
- Serial/Lot Numbers: 22257490683
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03