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
Reported: July 29, 2015 Initiated: June 19, 2015 #Z-2098-2015
Product Description
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
Reason for Recall
Incorrect expiration date on outer carton kit label
Details
- Recalling Firm
- CooperSurgical, Inc.
- Units Affected
- 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.
- Location
- Trumbull, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by CooperSurgical, Inc.. Units affected: 40 kits.
Why was this product recalled? ▼
Incorrect expiration date on outer carton kit label
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2098-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11