FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Recall number
- Z-1010-2026
- Recalling firm
- Applied Medical Resources Corp
- Product
- Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Status
- Open, Classified
- Initiated
- 2025-12-11
- Posted
- 2026-01-02
- Terminated
- not on file
- Reason
- There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- 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 removal60924496@appliedmedical.com 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical
- Quantity
- 450 units
- Distribution
- US: MI, CA, ME, OUS: France Great Britain, Germany
- Lot, serial or model codes
- UDI: (01)00607915126582; Lot # 1546141
- 510(k) numbers
- ["K060096"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28