FDA Device recall Z-1010-2026
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 by Applied Medical Resources, citing there is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-11 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Applied Medical Resources |
| Distribution | CA, ME, MI |
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.
Identifiers
| code_info | UDI: (01)00607915126582; Lot # 1546141 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2026%22
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