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FDA Devices recall · Reported November 19, 2014

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 to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

Recall #
Z-0207-2015
Affected scope
17 units
Initiated
September 30, 2014
Compiled from official public sources by the editorial team.
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CooperSurgical, Inc. recalled CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 … - a low-severity action.

CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 … was recalled by CooperSurgical, Inc. in November 19, 2014. Reason: Incorrect expiration date printed on the MILEX PESSARY KIT packaging. Check the official notice for the remedy. Verify recall #Z-0207-2015 with the FDA Devices before acting.

The recall

CooperSurgical, Inc. issued this low-severity FDA Devices recall-Incorrect expiration date printed on the MILEX PESSARY KIT packaging.

Low
severity level
17 units
affected scope
Class III
classification
November 19, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0207-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0207-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on September 30, 2014. It is classified under Low severity (Class III), with a current status of Terminated. CooperSurgical, Inc. is listed as the recalling firm, operating out of Trumbull, CT. Federal records list the affected scope as 17 units.

The documented reason for this recall is: Incorrect expiration date printed on the MILEX PESSARY KIT packaging Distribution data in the federal record shows the product reached: US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Low

Affected scope

17 units

Related Recalls

6

3 from same agency

Product description

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 to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues

Reason for recall

Incorrect expiration date printed on the MILEX PESSARY KIT packaging

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number Z-0207-2015
Date reported November 19, 2014
Date initiated September 30, 2014
Recalling firm CooperSurgical, Inc.
Firm location Trumbull, CT
Affected scope 17 units
Distribution US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

17 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0207-2015) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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 to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a non-invasive method assessing or resolving pelvic organ prolapse and stress incontinence issues. Recalled by CooperSurgical, Inc.. Units affected: 17 units.
Why was this product recalled?
Incorrect expiration date printed on the MILEX PESSARY KIT packaging
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2014. Severity: Low. Recall number: Z-0207-2015.
Where was the recalled product distributed?
Distribution: US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL.
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-0207-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.