Z-1010-2026Class II

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

Name: Z-1010-2026 Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Creator: Applied Medical Resources Corp
Published: 2025-12-11
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2025-12-11 / Open, Classified / root cause: manufacturing process

FDA source

Applied Medical Resources Corp began a recall of Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23 on 2025-12-11. FDA classified it as Class II and gives the reason as "There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1010-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-11
Posted: 2026-01-02
Recalling firm: Applied Medical Resources Corp
Product: Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Root cause tag: manufacturing process
FDA 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 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
Quantity in commerce: 450 units
Distribution: US: MI, CA, ME, OUS: France Great Britain, Germany
Product codes and lots: UDI: (01)00607915126582; Lot # 1546141

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-02

Product code GCJ

K060096Class IIModular Trocar SystemApplied Medical Resources Corp. / cleared 2006-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)