MILEX MXFIT0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937012576), received between May 25, 2023 and May 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K904026); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USE OF MILEX WAS DISCONTINUED DUE TO FEVER AND ALLERGIC REACTIONS OF URTICARIA IN THE NECK AND WHOLE BODY, AFTER THE PATIENT TRYING ON THE SUPPORT RING. NO ADDITIONAL INFORMATION WAS PROVIDED. 1216677-2023-00087 MXFIT0023 RING 76MM (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17005014 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K904026. One submission often covers many models, so check the product and lot details in each record.

• Z-2054-2017 · Apr 10, 2017 · Terminated
  CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient
• Z-1239-2015 · Feb 9, 2015 · Terminated
  CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
• Z-0207-2015 · Sep 30, 2014 · Terminated
  CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used
• Z-0208-2015 · Sep 30, 2014 · Terminated
  CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device use
• Z-1005-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 A pessary is a medical device that is inserted into the vagina to function as a suppo
• Z-1008-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportive
• Z-1011-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of th
• Z-1007-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 A pessary is a medical device that is inserted into the vagina to function as a supportiv
• Z-1009-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A pessary is a medical device that is inserted into the vagina to function as a supportive s
• Z-1010-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary is a medical device that is inserted into the vagina to function as a supportive structure
• Z-1006-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a suppo
• Z-1004-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a su
• Z-1012-2013 · Feb 26, 2013 · Terminated
  Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A pessary is a medical device that is inserted into the vagina to function as a supportive