Agency classClass IOur severity:Critical FDA (Devices)·Z-0154-2026·Announced 2025-10-29

IV burette sets recalled over missing internal shutoff valve component

ICU Medical is recalling 23,203 IV administration sets because the burette component is missing an internal shutoff valve intended to stop fluid flow.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the Critical tier.

Plain-English summary

IV administration sets are being recalled, covering the 23-inch 150 mL Burette Set with Clave and shut off (REF B33359), the 23-inch 150 mL Burette Set with shut off, MicroClave and clamp (REF B9213), and the 70-inch 150 mL Burette Set with Clave, shut-off and 3-way stopcock.

The IV gravity burette administration set's burette component is missing an internal shutoff valve intended to stop fluid flow. If used, the firm states this may result in a delay in therapy during setup, over delivery or unrestricted flow, or air being infused into the body.

The recall covers 23,203 units, with lots including 14070544 and 14126963 for REF B33359 and 14130197 for REF B9213. Distribution was worldwide, including Texas and South Carolina in the United States and Canada and Australia among other countries. The FDA has classified the recall as Class I.

Facilities should quarantine affected lots and follow ICU Medical's instructions.

The recalled product

Product: IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV set
Hazard: missing-component
unrestricted-flow
air-infusion
intravenous
Affected units: 23,203

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 (10)

REF/UDI-DI/Lot: B33359/10887709007823/14070544
14126963
B9213/10840619045859/14130197
B9732/10887709015033/14149636
B9733/10887709015040/14176779
011-C7014/10840619005068/14029638
14065820
14110075
14211300
14129823

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · ICU Medical, Inc.

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