Cardinal Health Recalls Sterile Femoral Angiography Drapes Due to Sticking Defect
Cardinal Health is recalling 936 units of sterile femoral angiography drapes because a manufacturing variance causes the plastic film to stick, preventing proper application.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a functional defect (sticking) that prevents proper application, which aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 936 units of the Femoral Angiography Drape Sterile. The recall affects Catalog Number 29560, specifically Lot 20LQR067 (expiration date 2025-11-01) and Lot 20MQR023 (expiration date 2025-12-01). The products were distributed nationwide to 45 states and the District of Columbia, as well as to Australia and Canada.
The recall was initiated because a manufacturing variance in the plastic film used to manufacture the products is causing the drapes and leggings to stick. This defect may prevent the products from being unfolded and applied properly during medical procedures.
Healthcare facilities and consumers who have these specific products should stop using them and contact Cardinal Health for further instructions or a return. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Femoral Angiography Drape Sterile
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 936
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number 29560
Distribution
Part of a larger recall action
This product is one of 5 recalled by Cardinal Health 200, LLC 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.
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