Z-2098-2015Class II

Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20

Name: Z-2098-2015 Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20
Creator: CooperSurgical, Inc.
Published: 2015-06-19
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-06-19 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive... on 2015-06-19. FDA classified it as Class II and gives the reason as "Incorrect expiration date on outer carton kit label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2098-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-19
Posted: 2015-07-17
Terminated: 2016-02-01
Recalling firm: CooperSurgical, Inc.
Product: Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice
Product code: HDX Dilator, Vaginal
Reason for recall: Incorrect expiration date on outer carton kit label
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: CooperSurgical sent an Urgent Medicall Device Recall dated June 19, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected products and complete the attached Acknowledgement and Receipt Form for a replacement. For questions call 203.601.5200.
Quantity in commerce: 40 kits
Distribution: US Nationwide Distribution in the states of: CA, FL, GA, HI, IL, KY, MD, MN, NC, NY, OH, TX, VT, and W A.
Product codes and lots: LOT 156966

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2098-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2098-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code HDX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)