Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2098-2015 — 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

U.S. FDA — Device Enforcement · United States · 2015-06-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2098-2015
Date of alert: 2015-06-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: CooperSurgical, Inc.
Product category: device
Product type: Devices

Reported risk: Incorrect expiration date on outer carton kit label

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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