FDA Medical devices recall ·
Kii Low Profile, Bladed Dual Pack , Qty recall
- Recall number
- Z-1010-2026
- Date
- (initiated December 11, 2025)
- Company / brand
- Applied Medical Resources Corp
22872 Avenida Empresa, Rancho Santa Margarita, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 450 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Why was it recalled?
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: (01)00607915126582; Lot # 1546141
Distribution
US: MI, CA, ME, OUS: France Great Britain, Germany
States: California Maine Michigan
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1010-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.