FDA recall, , Moderate risk
Applied Medical Kii Low Profile Bladed Dual Pack
Kii Low Profile, Bladed Dual Pack has a potential for extended blade obturator length after assembly.
Summary by Recall Canary from the FDA notice
What happened
Applied Medical Resources Corp, of Rancho Santa Margarita, California, began a recall of the Kii Low Profile, Bladed Dual Pack, Qty. 1 5x55mm on December 11, 2025, because there is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. The FDA added the recall to its Enforcement Report on January 2, 2026.
The recalled product was distributed in the United States in Maine, California and Michigan, and outside the U.S. in France, Great Britain and Germany. The recall was classified by the FDA on January 2, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- UDI-DI
- 00607915126582
- Lot code
- 1546141
Recall details
- Company began the recall
- Sold in
US: Michigan, California, Maine, OUS: France Great Britain, Germany
- Company
- Applied Medical Resources CorpRancho Santa Margarita, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98191
- Recall number
- Z-1010-2026
- Quantity recalled
- 450 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
