TEMED
Temed · Model P2514 · UDI-DI 05060660970025
1
510(k) clearances
7,600
Adverse events (34 deaths)
29
Recalls
141
Facilities
Description
TEMED Gas Diffuser A device designed for controlled diffusion of a medical gas [e.g., carbon dioxide (CO2), humidified air] into an open surgical wound during an open surgical gas insufflation procedure, typically to minimize the risk of air embolism or reduce heat transfer from the surgical wound. The diffuser typically includes connection tubing and may also include a filter. This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-16 | Olympus Corporation of the Americas | Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
| 2026-05-14 | ConMed Corporation | Potential for overpressure alerts. |
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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.