Cardinal Health: Medical Device Recall in 2021 - (Recall #: Z-0370-2022)

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:

SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041

Product Classification:

Class II

Date Initiated: November 2, 2021

Date Posted: December 22, 2021

Recall Number: Z-0370-2022

Event ID: 89015

Reason for Recall:

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

Status: Ongoing

Product Quantity: 231,219 units

Code Information:

Lot Numbers: 20MJQ001 20MJQ002 21AJQ001 21AJQ002 21AJQ003 21AJQ004 21AJQ005 21AJQ006 21BJQ001 21BJQ002 21CJQ001 21DJQ001 21DJQ002 21DJQ003 21EJQ001 21EJQ002 21EJQ003 21EJQ004 21FJQ001 21FJQ002 21FJQ003 21GJQ001 21GJQ002 21HJQ001 21HJQ002 21HJQ003 21HJQ004 21HJQ005 21HJQ006 21JJQ001 21JJQ002 21JJQ003 UDI: 50885380172494 (cs) 10885380172496 (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