Cooper Surgical Cube Pessary Recalled for Mislabeled Outer Packaging
Cooper Surgical is recalling 70 units of Cube Pessaries because the outer packaging may not reflect the actual size of the product inside.
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 indicates the product is unlikely to cause adverse health consequences. The issue is a packaging labeling error rather than a direct safety hazard.
Plain-English summary
Cooper Surgical, Inc. is recalling 70 units of the Cooper Surgical Cube Pessary, 1 5/8" (41mm), Milex Part Number MXKPEC04, Lot Number 117376. The recall was initiated because the outer package is mislabeled and may not accurately reflect the size of the pessary contained within.
A pessary is a medical device inserted into the vagina to provide support for the uterus, bladder, and rectum. The affected units were distributed nationwide in the United States and internationally to Australia, Canada, Colombia, Denmark, France, Holland, New Zealand, and Thailand.
Consumers who have this specific product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 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
- 70
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:117376
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
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