C.R. Bard Recalls Pediatric Foley Catheters with Incorrect Valve Cap Labeling
C.R. Bard is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters because the valve cap displays an incorrect inflation volume of 10 ml instead of 5 ml.
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: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect inflation volume printed on the cap) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
C.R. Bard, Inc., Urological Division is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters with a 3cc balloon. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. The recall is due to a labeling error where the valve cap incorrectly displays an inflation volume of 10 ml instead of the correct 5 ml.
The affected product is identified by Catalog # 165808 and Lot # NGWA1111. The units were distributed nationwide in the USA and Puerto Rico. The product is packaged individually with 12 units per corrugated case.
Consumers and healthcare facilities should stop using the affected catheters and contact C.R. Bard for instructions on how to return the product.
The recalled product
- Product
- 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
- Manufacturer
- C.R. Bard, Inc., Urological Division
- Hazard
- Affected units
- 4,032
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 (2)
- Catalog # 165808
- Lot # NGWA1111
Distribution
Related recalls
Same manufacturer · C.R. Bard, Inc., Urological Division
See all →- HighBard Foley procedural trays recalled due to incomplete sterile seals
FDA (Devices) · 2012-09-19
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateC.R. Bard Recalls Foley Catheters Due to Labeling Error
FDA (Devices) · 2016-04-20
- ModerateBard Foley Catheter Recalled for Incorrect Inflation Volume Labeling
FDA (Devices) · 2016-04-20
- ModerateBard Foley Catheter Recall Due to Incorrect Inflation Volume Labeling
FDA (Devices) · 2016-04-20
- ModerateBardex Foley Catheter Recalled for Incorrect Retainer Cap Print
FDA (Devices) · 2018-06-13
- LowC.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error
FDA (Devices) · 2015-11-11
- ModerateC.R. Bard Recalls Misbranded Antibacterial Intermittent Catheters
FDA (Devices) · 2016-11-23