Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CooperSurgical Dilator/Sound Set Recalled by CooperSurgical, Inc. Due to The seal of the sterile pouch may be...
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 CooperSurgical, Inc. directly.
Affected Products
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Quantity: 1740 units/174 boxes
Why Was This Recalled?
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Where Was This Sold?
This product was distributed to 25 states: AZ, CA, CT, DE, FL, GA, IN, IA, MA, MI, MN, MO, NH, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WI, DC
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report