The Recall Desk
HighFDA (Devices)·Z-0369-2022·Announced 2021-12-22

Cardinal Health Surgical Gowns Recalled for Potential Packaging Seal Defects

Cardinal Health is recalling 169,262 SmartSleeve surgical gowns due to potential package seal defects that could compromise sterility. Multiple affected lot numbers span 2020-2021 production with worldwide distribution.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential for seal compromise affecting sterility—rather than documented harm. Surgical gowns are sterile medical devices where package integrity is critical, meeting the High severity threshold for risk-of-harm products without reported injury.

Plain-English summary

Cardinal Health is recalling 169,262 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns, size Large (SKU: 9011), due to defects in package seals.

The recalled gowns may have open or compromised packaging seals that could compromise sterility. These are sterile medical devices intended for surgical use, where package integrity is essential to maintain sterility assurance.

The affected gowns were distributed worldwide, including throughout the United States, Canada, Chile, Thailand, Israel, and Latin America (Panama, Mexico, Colombia, Costa Rica), as well as Qatar. The recalled lot numbers are: 20MFQ001, 20MFQ002, 20MFQ003, 21AFQ001, 21BFQ001, 21BFQ002, 21CFQ001, 21CFQ002, 21CFQ003, 21DFQ001, 21DFQ002, 21EFQ001, 21EFQ002, 21FFQ001, 21FFQ002, 21GFQ001, 21GFQ002, 21GFQ003, 21HFQ001, and 21JFQ001.

If you have received or are in possession of any of these gowns, do not use them. Contact Cardinal Health or your supplier for instructions on return, replacement, or disposal. No illnesses or injuries related to this recall have been reported.

The recalled product

Product
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011
Manufacturer
Cardinal Health
Category
Medical Device — Surgical Gowns
Hazard
  • seal-defect
  • sterility-risk

Distribution

Distributed nationwide across the United States.

Related recalls

Same category