Foley Catheter Trays With Incorrect Material Identification Labels
SureStep Foley catheter trays are being recalled because their inserts have incorrect material labels. Users may confuse latex with silicone or vice versa, which could cause allergic reactions or infections.
What this means for you
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: FDA Class II medical device recall involving allergen mislabeling (latex is a common allergen causing serious allergic reactions) with additional potential infection risk. No illnesses have been reported; the hazard is theoretical but significant for latex-sensitive patients.
Plain-English summary
C.R. Bard Inc. is recalling 3,670 SureStep Foley Tray System BARD® Lubri-Sil Foley Catheter Trays (REF: A942216, Lot# NGJX4320) due to incorrect material identification on the catheter tray inserts.
The inserts on affected trays are labeled or identified incorrectly. Users may believe the catheter is made of silicone when it is actually natural rubber latex; or believe it is natural rubber latex with an infection-control coating when it is actually silicone hydrogel with an antimicrobial coating; or believe it is natural latex with infection control when it is actually silicone hydrogel coated without the antimicrobial coating. The mislabeling creates a risk of allergic reaction (particularly for patients with latex sensitivity) and potential infection.
These trays were distributed nationwide to healthcare facilities in multiple states including North Carolina, Florida, New York, Massachusetts, Minnesota, Texas, California, Ohio, Michigan, Washington, New Jersey, Illinois, Idaho, South Carolina, Indiana, Oklahoma, Oregon, Alabama, Virginia, Hawaii, Missouri, Mississippi, Maryland, Arizona, Kentucky, Georgia, Iowa, Colorado, New Mexico, Pennsylvania, Maine, Utah, and Nebraska.
The recalled product
- Product
- SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
- Manufacturer
- C.R. Bard Inc
- Hazard
- allergen-latex
- infection-risk
- mis-labeling
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)
- Lot# NGJX4320
Distribution
Distributed nationwide across the United States.
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