CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.
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 and involves a packaging-only documentation error (incorrect expiration date) with no reported adverse health consequences.
Plain-English summary
CooperSurgical, Inc. is recalling 6 units of MILEX Pessary Kits, specifically the Hodge w/Support Folding Pessary #1 (Model MXKPHS01). The recall is due to an incorrect expiration date printed on the product packaging.
The affected units are from Lot Number 142921. These devices were distributed in the United States to the states of Ohio, California, Wisconsin, Washington, Florida, Minnesota, New Hampshire, Rhode Island, Massachusetts, Illinois, Michigan, Iowa, and Alabama.
Consumers who have purchased these specific pessary kits should stop using them and contact CooperSurgical, Inc. for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 6
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: 142921
Distribution
Part of a larger recall action
This product is one of 2 recalled by CooperSurgical, 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 2 products in this recall →Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- SevereCooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
FDA (Devices) · 2026-09-30
- SevereCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- LowCooperSurgical Recalls MILEX Pessary Kits Due to Incorrect Packaging Labels
FDA (Devices) · 2015-11-18
- ModerateCooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error
FDA (Devices) · 2015-07-29
- LowCooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- LowCooper Surgical Incontinence Pessary Recalled for Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- LowCooper Surgical Incontinence Dish Pessary Recalled for Mislabeled Outer Packaging
FDA (Devices) · 2013-04-03
- ModerateCooperSurgical Pessary Kit Recalled for Incorrect Size Labeling
FDA (Devices) · 2015-03-11