CooperSurgical Cannula-Curette Recalled for Incorrect Curette Type
CooperSurgical is recalling 30 units of the Cannula-Curette 12MM (Lot 147234) because the product contains an incorrect curette type.
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 is unlikely to cause adverse health consequences. The issue is an incorrect component type without reported injuries.
Plain-English summary
CooperSurgical, Inc. is recalling 30 units of the Cooper Surgical CANNULA-CURETTE 12MM (Model Number: MX562, Lot Code: 147234). The recall was initiated because the product has been identified to contain an incorrect curette type.
The device is a sterile, disposable rigid plastic suction curette used to remove tissue from within the uterine cavity on an outpatient basis, particularly for endometrial sampling. The affected units were distributed in the United States, including the states of New York, Missouri, and Nevada.
Patients and healthcare providers who have used or possess this specific lot of the device should contact CooperSurgical, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 30
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 Code: 147234
Distribution
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