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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Kii Low Profile Bladed Dual Packs Recalled for Potential Extended Blade Length

Agency Publication Date: January 2, 2026
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Summary

This recall affects 450 units of the Kii Low Profile Bladed Dual Pack (model CTB23) surgical instrument. The manufacturer, Applied Medical Resources Corp, determined that the blade obturator may have an extended length after it is assembled into the cannula and seal housing. Healthcare providers and surgical facilities should stop using the affected lot immediately and contact the manufacturer to arrange for a return or replacement.

Risk

An extended blade obturator can lead to unintended tissue or organ punctures during surgical procedures, posing a significant injury risk to patients.

What You Should Do

  1. This recall affects the Kii Low Profile, Bladed Dual Pack (5x55mm) surgical device manufactured by Applied Medical Resources Corp.
  2. Identify affected products by checking for model number (REF) CTB23 and lot number 1546141 on the product label.
  3. The specific Unique Device Identifier (UDI) to look for is (01)00607915126582.
  4. Stop using the recalled device immediately. Contact Applied Medical Resources Corp or your medical equipment distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 with any additional questions about this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Kii Low Profile, Bladed Dual Pack (5x55mm)
Variants: Qty. 1 5x55mm
Model / REF:
CTB23
Lot Numbers:
1546141
UDI:
00607915126582

450 units affected total.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98191
Status: Active
Manufacturer: Applied Medical Resources Corp
Sold By: Medical distributors; Surgical centers; Hospitals
Manufactured In: United States
Units Affected: 450 units
Distributed To: Michigan, California, Maine

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.