CooperSurgical Recalls Fischer Cone Biopsy Excisor Due to Incorrect Packaging Size
CooperSurgical is recalling 500 units of the Fischer Cone Biopsy Excisor, Medium, because the products were packaged with an incorrect product size.
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: The recall is classified as FDA Class II and involves a packaging error (incorrect size) rather than a direct contamination or structural defect, fitting the criteria for moderate severity.
Plain-English summary
CooperSurgical, Inc. is recalling 500 units of the Fischer Cone Biopsy Excisor, Medium (5/Box), Model Number 900-151. The recall is being conducted because the products were packaged with an incorrect product size.
The affected products, identified by Lot number 212074, were distributed in California, South Carolina, Wisconsin, Michigan, New Hampshire, Maryland, Ohio, New Jersey, Australia, France, and Spain. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers who have these products should stop using them and contact CooperSurgical, Inc. for further instructions.
The recalled product
- Product
- Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 500
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: 212074
Distribution
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