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CLASS II · ModerateFDA

Applied Medical Resources Corp recalls Kii Low Profile

📅 Dec 11, 2025 · 📍 CA, ME, MI
Recalling company
Applied Medical Resources Corp
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Reason
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 11, 2025
Reported
Jan 14, 2026
Distribution
US: MI, CA, ME, OUS: France Great Britain, Germany
Status
Ongoing
Quantity
450 units
Lot / codes
UDI: (01)00607915126582; Lot # 1546141
Company location
Rancho Santa Margarita, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-1010-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1010-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.