Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm recallZ-1010-2026 · Applied Medical Resources Corp · initiated Dec 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Applied Medical Resources Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
Recall details
- Recall number
- Z-1010-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 11, 2025
- Posted by the FDA
- Jan 2, 2026
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 450 units
- Product code
- GCJ
- FDA submissions
- K060096
- Distribution
- US: MI, CA, ME, OUS: France Great Britain, Germany
Product description
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Code information (models, lots, serial numbers)
UDI: (01)00607915126582; Lot # 1546141
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Kii Low Profile Bladed Dual Pack CTB23Applied Medical Resources Corporation · Laparoscope, General & Plastic Surgery1 recall3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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