C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error
C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error rather than a physical defect or contamination.
Plain-English summary
C.R. Bard, Inc. is recalling 4,170 units of Antibacterial Hydro Personal Catheters, Male 12 Fr, Product Code 63512. The recall is due to incorrect unit labeling. While the case label and shelf box correctly identify the product as Product Code 63512 and Catheter Size 12 French, the individual unit label (catheter package) may incorrectly state Product Code 63516 and Catheter Size 16 French.
The affected product is sold in boxes of 30 units. The recall covers Lot 53620131. The product was distributed nationwide, including in California, Florida, Illinois, Missouri, New Jersey, Oregon, Pennsylvania, Texas, and Washington.
Consumers and healthcare facilities should stop using the affected catheters and contact C.R. Bard for further instructions or a replacement.
The recalled product
- Product
- Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 4,170
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 53620131
Distribution
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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02