Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brands
- CareFusion, BD, BD Alaris...
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CareFusion, BD, BD Alaris, CareFusion 303
- Product type
- Infusion Pump Accessories (Infusion Sets)
- Model numbers
- C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 11522558, 2410-0500 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
BD Alaris infusion pump systems and sets are used in clinical settings to deliver precise medications and fluids. Infusion sets connect to the pump and patient.
Why This Is Dangerous
If the infusion set or module functions outside prescribed ranges, it can lead to incorrect doses or timing, potentially harming patients.
Industry Context
This recall is part of ongoing vigilance for infusion devices and set components; however, no broader pattern is specified.
Real-World Impact
Hospitals and clinics may need to halt use of affected sets, adjust inventory, and coordinate with manufacturers for replacements, affecting workflow and patient safety.
Practical Guidance
How to identify if yours is affected
- Check if your infusion system is BD Alaris and compare reference numbers to the list.
- Inspect for SmartSite Y-Site components and Ball Valve configurations.
Where to find product info
Official recall notice on FDA enforcement page and manufacturer communications.
What timeline to expect
Notice issued 2025-09-11 with active status; replacements and refunds handled per recall process, typically weeks to months.
If the manufacturer is unresponsive
- Escalate to hospital risk management or biosafety officer.
- Contact the manufacturer for written guidance and escalation options.
How to prevent similar issues
- Vet suppliers and verify reference numbers before use.
- Implement stock control to segregate affected lots.
- Engage in routine device verifications and calibration checks.
Documentation advice
Keep copy of recall notice, serials, lot numbers, and all correspondence with suppliers and hospital administration.
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Product Details
Brand: CareFusion 303. Product: BD Alaris Pump Infusion Sets and compatible pump infusion sets. Reference numbers include C24101E, 10015414, 2447-0007, 24201-0007, 10012645, 2426-0500, 11522558, 2410-0500, 2232-0007, 11613191, 10012144, 10013034, 10013037, 11582773. Distribution: United States nationwide; international sites including United Arab Emirates, Australia, Belgium, Bahrain, Botswana, Canada, Switzerland, China, France, United Kingdom, Gibraltar, Israel, India, Kuwait, Mexico, Malaysia, Netherlands, New Zealand, Philippines, Pakistan, Qatar, Saudi Arabia, Singapore, Taiwan, South_Afr
Reported Incidents
No injury counts are provided in the submission. This section states a Class I recall with high hazard potential but does not list specific incidents or injuries.
Key Facts
- Class I recall
- High hazard potential
- US nationwide distribution; global reach
- Multiple reference numbers listed
- Immediate stop-use recommended
- Recall date 2025-09-11; report date 2025-10-15
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Safety Guide
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