Cardinal Health: Medical Device Recall in 2021 - (Recall #: Z-0376-2022)

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 X-large SKU: 9548

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: December 22, 2021

Recall Number: Z-0376-2022

Event ID: 89015

Reason for Recall:

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

Status: Ongoing

Product Quantity: 270,839 units

Code Information:

Lot Numbers: 20MMQ004 20MMQ005 20MMQ006 21AMQ005 21AMQ006 21BMQ006 21CMQ004 21CMQ005 21CMQ006 21CMQ007 21FMQ003 21FMQ004 21HMQ002 21HMQ006. UDI: 50192253006177 (cs) 10192253006179 (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