C.R. Bard Recalls Option-vf Urinary Catheters Due to Sterility Concerns
C.R. Bard is recalling 274 units of Option-vf Urinary Catheters because an FDA inspection found them to be potentially nonsterile.
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: The recall involves a sterile medical device found to be potentially nonsterile, which poses a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard, Inc. is recalling 274 units of Option-vf Urinary Catheters. These are sterile, prescription-only devices intended for female use and are latex-free.
The recall was initiated after an FDA inspection determined that the catheters were potentially nonsterile. The affected products are identified by Catalog No. FV14218 and Lot Nos. P1007637, P1007638, and P1007461, with an expiration date of 08/01/2016.
The devices were distributed in the United States to the states of AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI. Consumers and healthcare providers should stop using these specific lots and contact C.R. Bard for further instructions.
The recalled product
- Product
- Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 274
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 (3)
- Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637
- P1007638
- P1007461. Exp Date: 08/01/2016.
Distribution
Part of a larger recall action
This product is one of 2 recalled by C.R. Bard, Inc. 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 2 products in this recall →Related recalls
Same manufacturer · C.R. Bard, Inc.
See all →- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- ModerateUreteral stent kits recalled because the stent size may not match the label
FDA (Devices) · 2025-12-17
- ModerateUreteral stent kits, 4.7 French, recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17
- ModerateShort ureteral stent kits recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17
- ModerateUreteral stent kits, 8 French, recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17
Same hazard · infection risk
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighMedline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration
FDA (Devices) · 2026-08-19
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29