Z-1010-2026 Class II Ongoing
FDA device recall Z-1010-2026 was initiated by Applied Medical Resources Corp on December 11, 2025 and is designated Class II. Reason for recall: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. The recall status is ongoing. Affected quantity: 450 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 450 units
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.
Distribution Pattern
US: MI, CA, ME, OUS: France Great Britain, Germany
Code Information
UDI: (01)00607915126582; Lot # 1546141