Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit Recalled by CooperSurgical, Inc. Due to The current secondary packaging, a box, incorrectly states...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.
Affected Products
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
Quantity: 7126 units (total for all products)
Why Was This Recalled?
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the Instructions for Use (IFU) correctly states that the pessary is manufactured from latex rubber.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report