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

FDA Recall #Z-1010-2026 — Class II — December 11, 2025

Recall #Z-1010-2026 Date: December 11, 2025 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Applied Medical Resources Corp — Rancho Santa Margarita, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

450 units

Distribution

US: MI, CA, ME, OUS: France Great Britain, Germany

Code Information

UDI: (01)00607915126582; Lot # 1546141

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated