Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Kii Fios First Entry Recalled by Applied Medical Resources Corp Due to The product may not have met sterility requirements...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Applied Medical Resources Corp directly.
Affected Products
Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.
Quantity: 2,016 units
Why Was This Recalled?
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Applied Medical Resources Corp
Applied Medical Resources Corp has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report