ICU Medical, Inc. medical device recall: IV Administration sets. 23
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97698
- Recall initiated
- Oct 2, 2025
- Classified by FDA
- Oct 23, 2025
- Posted in Enforcement Report
- Oct 29, 2025
- Recalling firm
- ICU Medical, Inc.
- Firm location
- San Clemente, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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 the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Oct 2, 2025. FDA classified it 21 days later, on Oct 23, 2025. Distribution reported by FDA: Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand. ICU Medical, Inc. has 75 recalls in our records.
Recalled products (1)
Z-0154-2026 Class I Ongoing
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
Codes / lots: 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
Quantity: 23203
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97698
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.