IV Administration sets recallZ-0154-2026 · ICU Medical, Inc. · initiated Oct 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
ICU notified consignees via email with an "URGENT MEDICAL DEVICE CORRECTION" on about 10/02/2025. Consignees were instructed to: 1) Check all inventory locations within your institution for the affected products and discontinue use. Destroy all affected products following your institution s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. 2) Share this notification with all potential users of the device, to ensure they are aware of this notification. If the devices are used at another location, please ensure this communication is delivered there. 3) Complete and return the attached Customer Response Form to [email protected] within 10 days of receipt to acknowledge your understanding of this notification. 4) If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]. ICU Medical will provide replacement products to affected customers upon receipt of a complete Customer Response Form to certify product destruction. If you have any questions, contact Customer Service via email: [email protected] or call 1-(800)-258-5361 Additional information or technical assistance.
Recall details
- Recall number
- Z-0154-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 2, 2025
- Posted by the FDA
- Oct 23, 2025
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 23203
- Product code
- FMG
- FDA submissions
- K964435
- Distribution
- Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- ICU Medical B9733Icu Medical, Inc. · Stopcock, i.V. Set1 recall1 report
- ICU Medical B9213Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical B33359Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
- ICU Medical B9732Icu Medical, Inc. · Stopcock, i.V. Set1 recall0 reports
Other devices under the same FDA submission
559 devices cleared under K964435 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ICU Medical AC135Icu Medical, Inc. · Stopcock, i.V. Set1 recall10 reports
- ICU Medical MC330174Icu Medical, Inc. · Stopcock, i.V. Set1 recall4 reports
- ICU Medical Z2587Icu Medical, Inc. · Stopcock, i.V. Set1 recall3 reports
- ICU Medical B90111Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B9535Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B9650Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical Z3239Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical Z3626Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical MRSA60-84Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical AM3020Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B33971Icu Medical, Inc. · Stopcock, i.V. Set1 recall2 reports
- ICU Medical B3065Icu Medical, Inc. · Stopcock, i.V. Set1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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