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Milex MXFIT0810

by CooperSurgical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

13 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00888937012699 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

13 recalls · FDA

    • Terminated Z-2054-2017 FDA Class II initiated 10 Apr 2017

    The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.

    • Terminated Z-1239-2015 FDA Class II initiated 9 Feb 2015

    Incorrect size printed on the Milex Pessary Kit packaging label

  • 2 recalls, same reason

    • Terminated Z-0208-2015 FDA Class III initiated 30 Sep 2014
    • Terminated Z-0207-2015 FDA Class III initiated 30 Sep 2014

    Incorrect expiration date printed on the MILEX PESSARY KIT packaging

  • 9 recalls, same reason

    • Terminated Z-1008-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1011-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1004-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1007-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1012-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1005-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1010-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1006-2013 FDA Class III initiated 26 Feb 2013
    • Terminated Z-1009-2013 FDA Class III initiated 26 Feb 2013

    Pessary mislabeled outer package may not reflect the size of the product contained in the package

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Milex
Generic Name
Pelvic-organ-supporting pessary
Model / Reference
MXFIT0810
Primary DI / UDI-DI
00888937012699
510(k) Number
FDA Product Code
HHW
GMDN Term
Pelvic-organ-supporting pessary
Device Class
Class II
Regulation Number
884.3575
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Pelvic-organ-supporting pessary

Cleared under the same submission (K904026)

Show all (12)

Other devices from CooperSurgical, Inc.

See all devices from CooperSurgical, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No