Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
FDA Recall Z-1010-2026 · Posted 2026-01-02
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Recalling FirmApplied Medical Resources Corp
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2025-12-11
Product Quantity450 units
Reason for Recall
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
US: MI, CA, ME, OUS: France Great Britain, Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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