Recall Z-1010-2026 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
| Date | Jan 2, 2026 (initiated Dec 11, 2025) |
| Status | Open, Classified |
| Reason | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| Root cause | Nonconforming Material/Component |
| Action | On December 11, 2025, Applied Medical issued a Urgent Medical Device Recall Notification to affected consignees via Email. Applied Medical ask consignees to take the following actions: 1. Check your inventory for recalled product. 2. Quarantine any product from the impacted lot. 3. Complete the attached Customer Recall Notification Confirmation Form. Please note that you must return the form even if you have no devices in inventory. 4. Please notify any facilities to which you distributed the affected product with a copy of this notification. Please also complete the Distributor Recall Not |
| Quantity | 450 units |
| Distribution | US: MI, CA, ME, OUS: France Great Britain, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060096 | MODULAR TROCAR SYSTEM Applied Medical Resources Corp., Jan 24, 2006 |