Cooper Surgical Incontinence Dish Folding Pessary Mislabeled Size Recall
Cooper Surgical is recalling Incontinence Dish Folding Pessaries because the outer package may not reflect the actual product size.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a packaging labeling error rather than a direct safety defect.
Plain-English summary
Cooper Surgical, Inc. is recalling 36 units of Incontinence Dish Folding Pessary #0, 55mm (Milex Part Number: MXKPCOND00). The recall is due to a labeling error where the outer package may not accurately reflect the size of the pessary contained within.
The affected product is a medical device inserted into the vagina to support the uterus, bladder, and rectum. The specific lot number is 114288. The product was distributed nationwide in the United States and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
Consumers should check their pessary packaging to ensure the size listed matches the product inside. If the size is incorrect, the device may not provide the intended support or fit properly.
The recalled product
- 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.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number:114288
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Cooper Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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