Qapel Medical Inc.

FDA Regulatory Profile

Qapel Medical Inc. appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1512-2025, Class I) was initiated on February 26, 2025.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1512-2025Class IHippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132.February 26, 2025