Cooper Surgical, Inc.: Pessary mislabeled outer package may not reflect the size of the product contained in the package

Agency Publication Date: March 27, 2013

Affected Products

Product: 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 supportive structure of the uterus and/or bladder and rectum.

Lot Number:117301

Lot Numbers:

Number

Product: 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 supportive structure of the uterus and/or bladder and rectum.

Lot Number:117443

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Number

Product: 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 supportive structure of the uterus and/or bladder and rectum.

Lot Number:111732

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Number

Product: 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 supportive structure of the uterus and/or bladder and rectum.

Lot Number:114288

Lot Numbers:

Number

Product: 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 structure of the uterus and/or bladder and rectum.

Lot Number:114287

Lot Numbers:

Number

Product: 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 structure of the uterus and/or bladder and rectum.

Lot Number:117560

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Number

Product: 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 of the uterus and/or bladder and rectum.

Lot Number:117568

Lot Numbers:

Number

Product: 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 the uterus and/or bladder and rectum.

Lot Number:117376

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Number

Product: 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 structure of the uterus and/or bladder and rectum.

Lot Number:121784

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Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64531

Status: Resolved

Manufacturer: Cooper Surgical, Inc.

Manufactured In: United States

Units Affected: 9 products (80 units; 18 units; 45 units; 36 units; 31 units; 275 units; 175 units; 70 units; 20 units)

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Number:117301

Lot Numbers:

Number

Lot Number:117443

Lot Numbers:

Number

Lot Number:111732

Lot Numbers:

Number

Lot Number:114288

Lot Numbers:

Number

Lot Number:114287

Lot Numbers:

Number

Lot Number:117560

Lot Numbers:

Number

Lot Number:117568

Lot Numbers:

Number

Lot Number:117376

Lot Numbers:

Number

Lot Number:121784

Lot Numbers:

Number