Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS 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
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Quantity: 5,334 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