CooperSurgical lnflatoball Pessary Recalled for Incorrect Latex-Free Labeling
CooperSurgical is recalling lnflatoball Latex Rubber Pessaries because the secondary packaging incorrectly states the product is latex-free, despite being made of 100% latex.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error (mis-labeling) regarding a common allergen (latex). While the hazard is significant for allergic individuals, the rubric classifies minor labeling errors and low-risk contamination as Moderate (Score 2), and there are no reported injuries or illnesses in the source text to elevate the score to High (Score 3) or above.
Plain-English summary
CooperSurgical, Inc. is recalling the lnflatoball Latex Rubber Pessary, which is sold as an individual unit and as part of the lnflatoball Pessary Kit. The product is a single-patient use pessary manufactured from natural latex rubber, used for treating cystocele and/or rectocele associated with procidentia or prolapse.
The recall is due to a labeling error on the secondary packaging (the box), which incorrectly states that the product is latex-free. The product is actually made with 100% latex. The label on the inner package containing the pessary and the Instructions for Use (IFU) correctly state that the pessary is manufactured from latex rubber.
A total of 7,126 units are affected. The products were distributed worldwide, including nationwide in the United States and in various international countries. Consumers with latex allergies should not use these products. CooperSurgical is the recalling firm.
The recalled product
- Product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 7,126
Distribution
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