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AESCULAP

Aesculap AG · Model EJ996 · UDI-DI 04046955813360

HIF Prescription

510(k) clearances

7,497

Adverse events (34 deaths)

Recalls

140

Facilities

Description

INSUFFL.NEEDLE D:2.1/150MM STERILE

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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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.