MilexRecalls & reported problems across all models
Coopersurgical, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Milex model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 1
We found 7 models of Milex by Coopersurgical, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2020 and May 27, 2025 — classified as 1 death, 7 malfunctions.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (6 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Milex recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, Classified
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1631-2022 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Milex problems
Device problems
- Material Too Rigid or Stiff6
- Patient Device Interaction Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Hypersensitivity/Allergic reaction1
- Rectovaginal Fistula1
Milex models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Milex MXPCON06Pessary, Vaginal1 recall0 reports
- Milex MXPGE2-1/4Pessary, Vaginal1 death2 reports
- Milex MXPGE2-1/2Pessary, Vaginal2 reports
- Milex MXPDO07Pessary, Vaginal1 report
- MILEX MXPGSS2-1/4Pessary, Vaginal1 report
- MILEX MXPSH2-3/4Pessary, Vaginal1 report
- MILEX MXFIT0023Pessary, Vaginal1 report
Recent Milex adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathMay 27, 2025Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE GELHORN PESSARY CREATED A HOLE BETWEEN THE PATIENT'S VAGINA AND THEIR RECTUM WHICH ALLOWED STOOL TO PASS THROUGH AND OUT OF THE VAGINAL OPENING. PATIENT IS SCHEDULED FOR SURGERY TO CORRECT THE FISTULA. UPDATE: JUNE 15, 2025: THE DANISH MEDICINE AGENCY HAS BEEN INFORMED FROM THE HEALTHCARE FACILITY THAT THE PATIENT INVOLVED IN THE INCIDENT HAS PASSED AWAY.
Patient problems: Rectovaginal Fistula
MAUDE report 22088946 ↗MalfunctionAug 24, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff
HEALTHCARE PROFESSIONAL REPORTED VIA COMPANY REPRESENTATIVE "HAVING STIFFNESS ISSUES WITH OUR GELLHORNS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17612496 ↗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 ↗MalfunctionDec 4, 2020Material Too Rigid or Stiff
REPORT STATED: "THE CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF". 1216677-2020-00285-1 MXPSH2-3-4 SHAATZ PESSARY 2-3-4 E-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10949683 ↗MalfunctionNov 23, 2020Material Too Rigid or Stiff
THE PESSARY IS TOO STIFF. DONUT PESS 3 3-4 IN 7 MXPDO07 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10886062 ↗MalfunctionNov 23, 2020Material Too Rigid or Stiff
THE PESSARY IS TOO STIFF. GELLHORN PESS FLEX 2 1-2 MXPGE2 1-2 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10885481 ↗MalfunctionNov 22, 2020Material Too Rigid or Stiff
THE PESSARY IS TOO STIFF. GELLHORN PESS FLEX 2 1-4 MXPGE2 1-4 E-COMPLAINT-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10881831 ↗MalfunctionNov 22, 2020Material Too Rigid or Stiff
REPORT STATED: "THE CUSTOMER HAS ISSUED A CUSTOMER DISSATISFACTION COMPLAINT SOME TIME AGO SAYING THE PESSARIES ARE TOO STIFF". 1216677-2020-00269-1 MXPGSS2-1/4 PESS.SH.STEM FLEX 2-1/4 E-COMPLAINT: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10881796 ↗
Other Coopersurgical, Inc. products
All Coopersurgical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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