Medical device recalls Moderate risk

Applied Medical Resources Corp recalls Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Recall date
December 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1010-2026
FDA classification
Class II
Brand / firm
Applied Medical Resources Corp
Sold / distributed
US: MI, CA, ME, OUS: France Great Britain, Germany

Why it was recalled

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

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