The Recall Desk
HighFDA (Devices)·Z-0509-2023·Announced 2022-12-21

Surgical Procedure Kits Recalled for Potential Sterility Seal Defect

Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses reported.

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: FDA Class II recall of medical procedure kits with potential sterility breach from manufacturing defect. No illnesses or injuries reported; hazard is theoretical, not confirmed, placing this at Score 3 per rubric criteria.

Plain-English summary

Stradis Medical, LLC dba Stradis Healthcare is recalling Henry Schein Breast Pack surgical procedure trays and kits distributed nationwide in the US and Canada.

The kits may have incomplete sealing of the outer bag due to certain manufacturing conditions. This defect may result in a breach in the kit's sterility, which is essential for safe medical and surgical procedures.

No illnesses or injuries have been reported in connection with this recall. Affected consumers and healthcare facilities should contact the recalling firm for additional information about the recalled products.

The recalled product

Product
HENRY SCHEIN, BREAST PACK, Item No.570-2397
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Procedure Trays
Hazard
  • incomplete-seal
  • sterility-risk

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) H65857023971
  • UDI/DI (kit)M75257023970
  • Serial/Lot Numbers: 22235489451

Distribution

Distributed nationwide across the United States.

Related recalls

Same category