SourceMark

SOURCEMARK, LLC. · Model SM12400ES · UDI-DI 00813799005442

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2026-04-23	Covidien LLC	Temperature probe devices lack FDA clearance.
2026-04-23	Covidien LLC	Temperature probe devices lack FDA clearance.
2026-04-23	Covidien LLC	Temperature probe devices lack FDA clearance.
2011-09-26	Cincinnati Sub-Zero Products Inc	Reports 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.