Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
FDA device recall Z-1010-2026 · posted 2026-01-02 · Open, Classified
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- Action taken
- 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 Notification Confirmation Report. 5. Return the Recall Notification Confirmation Form to Applied Medical by emailing to removal60924496@appliedmedical.com 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 450 units
- Distribution
- US: MI, CA, ME, OUS: France Great Britain, Germany
- Date initiated
- 2025-12-11
- Date posted
- 2026-01-02
- Location
- Rancho Santa Margarita, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR TROCAR SYSTEM (K060096) | Applied Medical Resources Corp. | 2006-01-24 |