Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Wilson Penile Implantation System Retractor Frame Recalled by Applied Medical Technology Inc Due to The firm received a complaint of an open...
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 Technology Inc directly.
Affected Products
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Quantity: 2,263 Units
Why Was This Recalled?
The firm received a complaint of an open pouch which breaches the sterilization validation.
Where Was This Sold?
This product was distributed to 28 states: AL, AZ, AR, CA, CT, FL, GA, IN, IA, KS, KY, MD, MA, MI, MN, MO, NE, NH, NJ, NC, OH, PA, SC, TN, TX, UT, VA, WI
About Applied Medical Technology Inc
Applied Medical Technology Inc has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report