Surgical gowns recalled due to potential compromised sterility from packaging seals
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns due to potential open packaging seals that could compromise product sterility.
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 an FDA Class II recall for surgical gowns with potential for compromised sterility due to open packaging seals. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. Per the rubric, recalls with no reported illness and theoretical hazards are scored at most 3.
Plain-English summary
Cardinal Health is recalling 363,480 units of SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns in X-large, X-long size (SKU: 9041EL). The gowns are recalled due to a potential for open packaging seals that could compromise product sterility, which may affect the safety of surgical environments.
The affected gowns were distributed worldwide, including throughout the United States and to Chile, Thailand, Canada, Israel, and various Latin American countries. Multiple lot numbers are involved in this recall.
Healthcare facilities and providers who have received these gowns should immediately stop using them and contact Cardinal Health for return or replacement instructions. Users should verify their lot numbers against the recall list to determine if their inventory is affected.
The recalled product
- Product
- SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041EL
- Manufacturer
- Cardinal Health
- Affected units
- 363,480
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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