Kii Low Profile — Class II medical device recall Z-1010-2026
Ongoing recall by Applied Medical Resources Corp, reported 2026-01-14, distributed in CA, ME, MI. There is the potential for extended length of the blade obturator after assembly into the cannula and seal hou
| Recall number | Z-1010-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2025-12-11 |
| Classified | 2026-01-02 |
| Reported by FDA | 2026-01-14 |
| Distributed | CA, ME, MI |
| Countries outside the US | DE, FR, GB |
| Quantity | 450 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00607915126582 |
| Lot numbers | 1546141 |
| Model numbers | CTB23 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1010-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.