FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
- Recall number
- Z-2112-2020
- Recalling firm
- CooperSurgical, Inc.
- Product
- CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
- Status
- Terminated
- Initiated
- 2020-04-09
- Posted
- not on file
- Terminated
- 2021-05-11
- Reason
- The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 1740 units/174 boxes
- Distribution
- Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI
- Lot, serial or model codes
- Lot # 257589
- 510(k) numbers
- K183020
- PMA numbers
- not on file
- Product code
- HIH
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28