Kii Low Profile…

Date

Jan. 14, 2026

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Applied Medical Resources Corp

Product

Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Reason

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Distribution pattern

US: MI, CA, ME, OUS: France Great Britain, Germany

Quantity

450 units

Codes and lots

UDI: (01)00607915126582; Lot # 1546141

Recall started

Dec. 11, 2025

Device type

Laparoscope, General & Plastic Surgery

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

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

Recall number

Z-1010-2026

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1010-2026. The agency record governs; check it and the company before acting.