The Recall Desk
HighFDA (Devices)·Z-0376-2022·Announced 2021-12-22

RoyalSilk Surgical Gowns Recalled for Potential Sterility Compromise

Cardinal Health is recalling 270,839 units of RoyalSilk Non-Reinforced Surgical Gowns (X-large, SKU 9548) due to potential packaging seal failures that could compromise sterility.

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 classified this as a Class II recall. The hazard involves potential sterility compromise in surgical gowns, which are risk-of-harm medical products. No illnesses or adverse events have been reported in the source material.

Plain-English summary

Cardinal Health is recalling RoyalSilk Non-Reinforced Surgical Gowns, X-large (SKU 9548), with the following lot numbers: 20MMQ004, 20MMQ005, 20MMQ006, 21AMQ005, 21AMQ006, 21BMQ006, 21CMQ004, 21CMQ005, 21CMQ006, 21CMQ007, 21FMQ003, 21FMQ004, 21HMQ002, and 21HMQ006. The recall affects approximately 270,839 units.

The gowns are subject to recall due to the potential for packaging seals to open or fail, which could compromise the sterility of the surgical gowns. Maintaining a sterile field is essential for safe use of surgical gowns during medical procedures.

The recalled gowns were distributed worldwide, including throughout the United States and internationally to Canada, Chile, Costa Rica, Colombia, Israel, Mexico, Panama, Qatar, and Thailand.

Healthcare facilities and users with gowns from the affected lot numbers should discontinue use and contact Cardinal Health for instructions regarding replacement or return of the product.

The recalled product

Product
RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548
Manufacturer
Cardinal Health
Category
Medical Device — Surgical Supplies
Hazard
  • seal-failure
  • sterility-risk

Distribution

Distributed nationwide across the United States.

Related recalls

Same category