ICU Medical, Inc. IV Administration sets. 23" 150 mL Burette Set w/Clave, Luer Lock recall: IV Gravity burette administration set burette component is missing
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.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: 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.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0154-2026
- Published
- October 29, 2025
- Risk level
- Class I
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 23203
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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
- UPC codes
- 10887709007823, 10840619045859, 10887709015033, 10887709015040, 10840619005068
Products covered by this recall
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 Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
Check your product
The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 10887709007823
- 10840619045859
- 10887709015033
- 10887709015040
- 10840619005068
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- B33359
- 10887709007823
- 14070544
- 14126963
Model or item number
On the rating label, the box or the instruction sheet.
- B33359
- B9213
- B9732
- B9733
- 011-C7014 — REF
- UDI-DI
Package size
Match the net weight or the piece count on the front of the pack.
- 150 mL
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
ICU Medical, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: ICU Medical, Inc. — 951 Calle Amanecer, San Clemente, CA, 92673-6212
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical, Inc. medical devices recalled?
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. 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.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10887709007823, 10840619045859, 10887709015033; lot code B33359, 10887709007823, 14070544; model number B33359, B9213, B9732. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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