Cardinal Health RoyalSilk Surgical Gowns Recalled for Sterility Compromise
Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential packaging seal defects that could compromise sterility. The affected gowns were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II recall involving a medical device that poses a risk of harm in clinical use (sterility compromise during surgical procedures), but no illnesses or injuries have been reported. This fits the score 3 (High) criterion for risk-of-harm products without documented patient impact.
Plain-English summary
Cardinal Health is recalling 8,950 units of RoyalSilk Non-Reinforced Surgical Gowns (XXX-large, X-long, SKU 95998) due to potential defects in packaging seals. The recalled gowns may have open seals that could compromise their sterility.
The affected lot numbers are 20MMQ007, 21BMQ007, 21CMQ008, 21DMQ001, 21EMQ003, and 21FMQ007, identified by UDI codes 50192253006191 (case) and 10192253006193 (each). The gowns were distributed worldwide, including to the United States, Chile, Thailand, Canada, Israel, Qatar, Panama, Mexico, Colombia, and Costa Rica.
Surgical gowns with open packaging seals may not maintain the sterile barrier necessary for safe use in surgical procedures. Sterility compromise could expose patients to contamination during surgical interventions.
The recalled product
- Product
- RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998
- Manufacturer
- Cardinal Health
- Affected units
- 8,950
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Cardinal Health under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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Similar recalls
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