Silastic Brand Foley Catheters recalled due to surface stain
C.R. Bard Inc is recalling Silastic Brand Foley Catheters because of stain present on the surface of affected units. The recall affects 106,160 catheters distributed across the United States and Canada.
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: This is an FDA Class II recall. The source text identifies only a surface cosmetic defect (stain) with no reported illnesses, injuries, or evidence of patient harm. Per the rubric, Class II recalls without hospitalization reports are typically scored 2 (Moderate).
Plain-English summary
C.R. Bard Inc is recalling Silastic Brand Foley Catheters (30cc and 5cc models) due to stain present on the surface of affected catheters. The recalled products include Catalog Numbers 33416, 33418, 33420, 33422, 33424 (30cc) and 33614, 33616, 33618, 33620, 33622, 33624 (5cc), affecting approximately 106,160 units.
The affected catheters were distributed throughout the United States (including Alaska, Hawaii, and all 50 states) and Canada.
Consumers currently using affected catheters should contact their healthcare provider. Affected lot numbers are listed in the FDA recall notice Z-2226-2026. Healthcare facilities and distributors should verify they do not have affected product and quarantine any located units.
The recalled product
- Product
- Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Foley Catheter
- Hazard
- Affected units
- 106,160
Distribution
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