| Date Initiated by Firm | December 11, 2025 |
|---|
| Date Posted | January 02, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1010-2026 |
|---|
| Recall Event ID |
98191 |
| 510(K)Number | K060096 |
|---|
| Product Classification |
Laparoscope, general & plastic surgery - Product Code GCJ
|
| Product | Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm
REF: CTB23 |
|---|
| Code Information |
UDI: (01)00607915126582; Lot # 1546141 |
| FEI Number |
2027111
|
Recalling Firm/
Manufacturer |
Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688-2650
|
| For Additional Information Contact | Jaclene Rios-Simpson
949-713-8688 |
|---|
Manufacturer Reason
for Recall | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
|---|
FDA Determined
Cause 2 | 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 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 |
|---|
| Quantity in Commerce | 450 units |
|---|
| Distribution | US: MI, CA, ME,
OUS: France Great Britain, Germany |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = GCJ
|
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