Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0933-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: January 18, 2023

Recall Number: Z-0933-2023

Event ID: 91350

Reason for Recall:

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Status: Ongoing

Product Quantity: 1,040 units

Code Information:

Assembly Number 570-1130, UDI-DI: H65857011301, Lot Numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.

Distribution Pattern:

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Voluntary or Mandated:

Voluntary: Firm initiated