Food, drugs, devices › CooperSurgical, Inc.
Device recall: CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical M
FDA enforcement event 69500 is a device recall by CooperSurgical, Inc. of Trumbull, CT, initiated 30 Sep 2014 and classified Class III, with 2 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 28 May 2015. Initiation: voluntary: firm initiated. CooperSurgical, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CooperSurgical, Inc., Trumbull, CT.
Reason for recall
"Incorrect expiration date printed on the MILEX PESSARY KIT packaging"
Distribution
"US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0207-2015 | 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… | 17 units | Class III | Terminated | 19 Nov 2014 |
| Z-0208-2015 | 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 used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a… | 6 units | Class III | Terminated | 19 Nov 2014 |
Context
Other enforcement events for CooperSurgical, Inc.
All 57 events for CooperSurgical, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect expiration date printed on the MILEX PESSARY KIT packaging"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distibution in states of:OH, CA, WI, WA, FL, MN, NH, RI, MA, IL, MI, IA, and AL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 May 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.