Recall Z-2226-2026— C.R. Bard Inc
Class II · Ongoing
Class II FDA medical device recall by C.R. Bard Inc, initiated 2026-04-23. It names one FDA 510(k) clearance: K951103. 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. Reason: Due to stain present on the surface of affected foley catheters..
- Recalling firm
- C.R. Bard Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-23
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Due to stain present on the surface of affected foley catheters.
Data sourced from openFDA. This site is unofficial and independent of the FDA.