Stradis Medical, LLC dba Stradis Healthcare: Medical Device Recall in 2022 - (Recall #: Z-0509-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

HENRY SCHEIN, BREAST PACK, Item No.570-2397

Product Classification:

Class II

Date Initiated: November 2, 2022

Date Posted: December 21, 2022

Recall Number: Z-0509-2023

Event ID: 91124

Reason for Recall:

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Status: Ongoing

Product Quantity: 8 units

Code Information:

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

Distribution Pattern:

US nationwide distribution, and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated