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Level 1

ICU MEDICAL, INC. · Model ESTC-12 · UDI-DI 30695085000239

BZT Prescription
1
510(k) clearances
30
Adverse events
4
Recalls
23
Facilities

Recalls

DateFirmReason
2026-04-23Covidien LLCTemperature probe devices lack FDA clearance.
2026-04-23Covidien LLCTemperature probe devices lack FDA clearance.
2026-04-23Covidien LLCTemperature probe devices lack FDA clearance.
2011-09-26Cincinnati Sub-Zero Products IncReports that the Rectal/ Esophageal Temperature Probes are not reading correctly. This situation causes the Blanketrol device, which the probes connect to, to shut down operation a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.