Recall archive / FDA device enforcement
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 — FDA record Z-1010-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 450 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1010-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: (01)00607915126582; Lot # 1546141 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MI, CA, ME, OUS: France Great Britain, Germany
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 14, 2026
- Recall initiation date
- Dec 11, 2025
- Center classification date
- Jan 2, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.