Use cautionMedical device recall · FDA · Published October 2, 2025
ICU Medical IV Burette Sets Risk: Missing Shutoff Valve May Cause Over Delivery
ICU Medical recalls 23" 150 mL IV burette sets with missing shutoff valve that could lead to over delivery or air infusion. Affected units include specific model numbers and serial ranges.
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.
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Contact the company
📍Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212
✎ GovInfoNow plain-language explainer
ICU Medical is recalling IV administration sets that have a missing internal shutoff valve. This could cause over delivery of fluids or air being infused into the body during medical treatment. Affected products include specific model numbers and serial ranges. Read more at govinfonow.com/recall/51118-icu-medical-iv-burette-sets-risk-missing-shutoff-valve-may.
“ICU Medical IV Burette Sets Risk: Missing Shutoff Valve May Cause Over Delivery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51118-icu-medical-iv-burette-sets-risk-missing-shutoff-valve-may. Based on FDA recall #Z-0154-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0154-2026%22&limit=1).
The FDA announced on Oct. 2, 2025, that ICU Medical, Inc. is recalling IV administration sets due to a missing internal shutoff valve. This defect may cause over delivery of fluid or air infusion into the body.
How to tell if you have it
Brand: ICU Medical
Product: 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359
Product: 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213
Distribution: US (nationwide) to TX, SC; Canada, Australia, New Zealand
The hazard
The IV gravity burette administration set's burette component is missing an internal shutoff valve intended to stop fluid flow. If used, this defect may result in delay in therapy during setup, over delivery or unrestricted flow, or air being infused into the body.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent similar recalls include an Aug. 20, 2026 recall of ICU Medical CADD Yellow Medication Cassette Reservoirs for leakage risk and a June 24, 2026 recall of ICU Medical Hotline Fluid Warming Sets for leakage risk in specific lots. Other recent recalls of similar products include B Braun IV Burette Set Recall (Oct. 29, 2025) and B Braun Medical IV Sets Recall (Oct. 29, 2025).
How to tell if you have this one
Check for model numbers like B33359, B9213, B9732, or B9733 on the product. The sets are 23" to 80" long and include specific components like Clave, Luer Lock, or 3-Way Stopcock. Serial numbers and lot codes are listed in the recall notice.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model numbers (B33359, B9213, B9732, B9733) and serial numbers on the IV set.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: South Carolina, Texas.
Recall timeline
FDA published this recall 27 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0154-2026 (October 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0154-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.