Agency classClass IIOur severity:High FDA (Devices)·Z-0375-2022·Announced 2021-12-22

Cardinal Health Recalls RoyalSilk Surgical Gowns for Compromised Packaging Seals

Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns due to potential for open packaging seals that could compromise sterility. The recalled units 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 medical device recall for a risk-of-harm product (surgical gowns requiring sterility) where no illnesses or injuries have been reported. The compromise of packaging seals directly undermines the product's critical safety function, warranting a High severity rating.

Plain-English summary

Cardinal Health is recalling 364,481 units of RoyalSilk Non-Reinforced Surgical Gowns Large (SKU: 9518) due to potential for open packaging seals that could compromise the sterility of the surgical gowns.

The affected product was distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, Qatar, Panama, Mexico, Colombia, and Costa Rica. The recalled lot numbers are 20MMQ001, 20MMQ002, 20MMQ003, 21AMQ001, 21AMQ002, 21AMQ003, 21AMQ004, 21BMQ001, 21BMQ002, 21CMQ001, 21CMQ002, 21CMQ003, 21EMQ001, 21EMQ002, 21FMQ001, 21FMQ002, and 21HMQ001.

Surgical gowns must maintain sterility to prevent contamination during surgical procedures. Open packaging seals could allow contamination to occur prior to use. If you have received these gowns, do not use them and contact Cardinal Health or the FDA for instructions on returns or replacements.

The recalled product

Product: RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518
Manufacturer: Cardinal Health
Category: Medical Device — Surgical Gowns
Hazard: contamination-risk
packaging-defect
Affected units: 364,481

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 →

Same manufacturer · Cardinal Health

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