Kii Low Profile recall (Applied Medical Resources Corp)
Medical deviceClass IIOngoing
Summary: Applied Medical Resources Corp is recalling 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.
What is being recalled
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Why
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: MI, CA, ME, OUS: France Great Britain, Germany (states named: California, Maine, Michigan)
How to tell if yours is affected
UDI: (01)00607915126582; Lot # 1546141
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1010-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 11, 2025 |
| Reported | January 14, 2026 |
| Company | Applied Medical Resources Corp |
| Company location | Rancho Santa Margarita, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 450 units |
More recalls from Applied Medical Resources Corp · all medical device recalls · recalls from December 2025