Cardinal Health: Medical Device Recall in 2021 - (Recall #: Z-0375-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: December 22, 2021

Recall Number: Z-0375-2022

Event ID: 89015

Reason for Recall:

Potential for open packaging seals compromising the sterility of the surgical gowns

Status: Ongoing

Product Quantity: 364,481 units

Code Information:

Lot Numbers: 20MMQ001 20MMQ002 20MMQ003 21AMQ001 21AMQ002 21AMQ003 21AMQ004 21BMQ001 21BMQ002 21CMQ001 21CMQ002 21CMQ003 21EMQ001 21EMQ002 21FMQ001 21FMQ002 21HMQ001. UDI: 50192253006160 (cs) 10192253006162 (ea)

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica.

Voluntary or Mandated:

Voluntary: Firm initiated