CooperSurgical, Inc. CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
Lot # 257589
Products Sold
Lot # 257589
CooperSurgical, Inc. is recalling CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 due to The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Recommended Action
Per FDA guidance
CooperSurgical sent an Urgent Medical Device Recall letter dated April 9, 2020 to all customers that received lot number 257589 of the Milex Cervical Dilator P/N MX21 which could have a compromised finished seal (opposite the chevron seal) of the sterile pouch. Customers were instructed to inspect each package for damage, including the seal area, prior to use (product is acceptable for use if it is visually confirmed that the pouchs seal is intact). Customers should discontinue use of and quarantine products with any packaging irregularities. The firm requested that the customers complete and return the attached Acknowledgement and Receipt Form, whether or not they had any of the affected product on hand. CooperSurgical stated that they will arrange for product returns and replacement.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026