B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk
B Braun Medical Inc is recalling 68 Dialog+ Hemodialysis Conductivity Sensors due to a potential leakage hazard. The units were distributed nationwide to various states and territories.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are classified as Critical (Score 5) regardless of other factors.
Plain-English summary
B Braun Medical Inc is recalling 68 units of the Dialog+ Hemodialysis Conductivity Sensor (Item # 3456102A). The recall is being conducted because of a potential leakage issue with the sensors. These sensors are components used in Dialog+ Hemodialysis machines, which are prescribed for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure.
The affected sensors were distributed nationwide to facilities in North Dakota, Ohio, California, Virginia, Florida, Louisiana, South Carolina, Illinois, Utah, Arizona, Kentucky, Iowa, Wisconsin, Oklahoma, Tennessee, South Dakota, Alabama, New Jersey, Texas, New Mexico, New York, Kansas, Washington, Missouri, Colorado, Pennsylvania, Connecticut, Delaware, Georgia, Maryland, Puerto Rico, and St. Thomas USVI. The devices are used in hospital, health center, and outpatient dialysis center settings.
This is an FDA Class I recall. Healthcare facilities and consumers should stop using the affected conductivity sensors immediately and contact B Braun Medical Inc for instructions on replacement or return.
The recalled product
- Product
- Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis c
- Manufacturer
- B Braun Medical Inc
- Hazard
- Affected units
- 68
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)
- Item # 3456102A
Distribution
Part of a larger recall action
This product is one of 6 recalled by B Braun Medical 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 6 products in this recall →Related recalls
Same manufacturer · B Braun Medical Inc
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22