Cooper Surgical Cube Pessary Recalled Due to Mislabeled Outer Packaging
Cooper Surgical is recalling 20 units of Cube 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 FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Cooper Surgical, Inc. is recalling 20 units of the Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm (Milex Part Number: MXKPECH00). The recall was initiated because the outer package is mislabeled and may not accurately reflect the size of the product contained within.
The affected product is a medical device inserted into the vagina to support the uterus, bladder, and rectum. The specific lot number for the recalled units is 121784. The products were distributed worldwide, including nationwide in the United States and internationally to Australia, Canada, Colombia, Denmark, France, Holland, New Zealand, and Thailand.
Consumers who possess this specific lot of pessaries should stop using them and contact Cooper Surgical, Inc. for instructions on return or replacement. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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
- 20
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:121784
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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