Cardinal Health: Medical Device Recall in 2021 - (Recall #: Z-0377-2022)

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 XX-large SKU: 9578

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: December 22, 2021

Recall Number: Z-0377-2022

Event ID: 89015

Reason for Recall:

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

Status: Ongoing

Product Quantity: 9,990 units

Code Information:

Lot Numbers: 20MLQ001 21BLQ001 21CLQ001 21DLQ001 21DLQ002 21ELQ001 21ELQ002 21ELQ003 21GLQ001 21HLQ001. UDI: 50192253006184 (cs) 10192253006186 (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