Cooper Surgical Incontinence Ring Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 80 units of Incontinence Ring Flexible Pessaries because the outer packaging 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 issue is a packaging labeling error rather than a direct product defect or contamination.
Plain-English summary
Cooper Surgical, Inc. is recalling 80 units of Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm (Milex Part Number: MXPCON04). The recall was initiated because the outer package may be mislabeled and does not accurately reflect the size of the product contained within.
The affected units, identified by Lot Number 117301, were distributed nationwide in the United States and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand. A pessary is a medical device inserted into the vagina to function as a supportive structure for the uterus, bladder, and rectum.
Consumers who possess this specific product should stop using it and contact Cooper Surgical, Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Cooper Surgical, Inc.
- Hazard
- Affected units
- 80
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:117301
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.
See all 9 products in this recall →Related recalls
Same manufacturer · Cooper Surgical, Inc.
See all →- ModerateCooper Surgical Recalls LEEP RediKit Due to Incorrect Anesthetic Labeling
FDA (Devices) · 2013-04-10
- LowCooper Surgical Incontinence Dish Folding Pessary Mislabeled Size Recall
FDA (Devices) · 2013-04-03
- LowCooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- LowCooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- LowCooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- LowCooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels
FDA (Devices) · 2015-11-18
- LowCooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
FDA (Devices) · 2014-11-19
- ModerateCooperSurgical Pessary Kit Recalled for Incorrect Size Labeling
FDA (Devices) · 2015-03-11
- ModerateCooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging
FDA (Devices) · 2015-07-01
- ModerateCooper Surgical Recalls Omniflex Diaphragms Due to Packaging Labeling Error
FDA (Devices) · 2013-04-03
- ModerateCooperSurgical Recalls Mislabeled Os Finder Cervical Dilators
FDA (Devices) · 2020-07-15