Quick Facts at a Glance
- Recall Date
- December 11, 2025
- Hazard Level
- HIGH
- Brand
- Applied Medical Resources
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Applied Medical Resources
- Product type
- Cannula
- Model numbers
- UDI: (01)00607915126582, Lot # 1546141
- Sold at
- Multiple Retailers
- Where affected
- MI, CA, ME
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 11, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Applied Medical Resources Corp or your healthcare provider for instructions. Notification method: Letter
About This Product
The Kii Low Profile, Bladed Dual Pack is a medical device used in various medical procedures. Healthcare professionals use this device for its precision and efficiency.
Why This Is Dangerous
The defect may cause the blade obturator to extend beyond the intended length, which can create significant risks during procedures requiring precise instrument use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should immediately stop using the affected cannula, which can lead to procedure delays and potential safety risks.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for UDI: (01)00607915126582 and Lot # 1546141.
- Verify if your cannula was purchased from the recalled distribution locations.
- Contact your healthcare provider or the manufacturer for verification.
Where to find product info
The UDI and lot number can typically be found on the packaging or the device itself.
What timeline to expect
Refund processing may take 4-6 weeks after returning the recalled product.
If the manufacturer is unresponsive
- Document your attempts to contact the manufacturer.
- Consider reaching out to regulatory agencies for assistance.
- Keep records of all communications regarding the recall.
How to prevent similar issues
- Look for devices with safety certifications from recognized organizations.
- Inquire about the manufacturer's history of recalls before purchase.
- Stay informed about FDA recalls in the medical device sector.
Documentation advice
Keep a record of your purchase, including receipts and any communication with the manufacturer regarding the recall.
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Product Details
The recalled product is the Kii Low Profile, Bladed Dual Pack, REF: CTB23. It has a UDI of (01)00607915126582 and Lot # 1546141. The product was distributed in Michigan, California, and Maine, as well as France, Great Britain, and Germany.
Key Facts
- Recall Date: December 11, 2025
- Hazard Level: High
- Distribution: US and several European countries
- No reported incidents or injuries
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Safety Guide
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