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LIFESOUND
NOVAMED-USA INC. · Model 10-1535-001 · UDI-DI 00817499020002
BZT
Prescription
10
510(k) clearances
30
Adverse events
4
Recalls
23
Facilities
Description
9FR ESOPHAGEAL STETHOSCOPE WITH 400 SERIES THERMISTOR
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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Get your free API keyRead the docsData 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.