Z-2112-2020Class II

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Name: Z-2112-2020 CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Creator: CooperSurgical, Inc.
Published: 2020-04-09
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2020-04-09 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21 on 2020-04-09. FDA classified it as Class II and gives the reason as "The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2112-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Posted: 2020-05-22
Terminated: 2021-05-11
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.
Root cause tag: packaging
FDA 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 in commerce: 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
Product codes and lots: Lot # 257589

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2112-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2112-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code HIH

K183020Class IIEndosee SystemCooperSurgical, Inc. / cleared 2019-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)