Quick Facts at a Glance
- Recall Date
- October 2, 2025
- Hazard Level
- HIGH
- Brand
- ICU Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- ICU Medical
- Product type
- IV Gravity Burette Set
- Model numbers
- B33359, B9213, B9732, B9733, 011-C7014, 14065820, 14110075, 14211300 +11 more
- Sizes
- 23" (58 cm), 70" (178 cm), 80" (203 cm), 53 cm (21")
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 2, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
IV gravity burette sets deliver measured IV fluids in controlled volumes for patient care in hospital settings. They come in multiple lengths and configurations to fit clinical workflows.
Why This Is Dangerous
A missing internal shutoff valve in the burette component can create delays in therapy, permit overdelivery, or allow air to be infused into a patient.
Industry Context
This recall is not stated to be part of a broader industry pattern.
Real-World Impact
Hospitals may experience workflow disruptions and potential patient safety risks if affected sets are used. Facilities should remove the recalled devices from service and follow replacement instructions.
Practical Guidance
How to identify if yours is affected
- Compare against ICU Medical recall list and FDA notice.
- Isolate and segregate any affected units.
- Contact ICU Medical for instructions on replacement or remediation.
Where to find product info
Recall details are on ICU Medical’s site and the FDA enforcement page. Look for model numbers and lot codes on device labeling.
What timeline to expect
Replacement or remediation timelines vary; expect several weeks for processing.
If the manufacturer is unresponsive
- Escalate to hospital risk management or procurement.
- File a report with the FDA if guidance is not provided.
- Document all communications with ICU Medical and suppliers.
How to prevent similar issues
- Verify device model numbers before use.
- Maintain an up-to-date recall log for all IV administration sets.
- Procure from authorized vendors and verify supplier recall notices.
- Post-purchase check: confirm devices have intact shut-off mechanisms before use.
Documentation advice
Keep recall notice, model/REF codes, lot numbers, purchase records, and correspondence with ICU Medical.
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Product Details
Model numbers/references: B33359; B9213; B9732; B9733; 011-C7014; 14065820; 14110075; 14211300; 14129823; 14126963; 14130197. Distribution: Worldwide distribution including the US nationwide and in TX and SC; Canada, Australia, New Zealand. Quantity recalled: 23,203 units. Brand: ICU Medical. Product: IV gravity burette sets with 150 mL burettes, various configurations (Clave, Shut-Off, MicroClave, 3-Way Stopcock, Rotating Luer, etc.). Recall date: 2025-10-02. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution including US (TX, SC) and Canada, Australia, New Zealand
- Model numbers include B33359, B9213, B9732, B9733, 011-C7014
- Internal shut-off valve missing in burette component
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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