CooperSurgical Recalls Blunt Hurd Cannula Due to Incorrect Package Insert
CooperSurgical is recalling 90 units of Blunt Hurd Cannula because the wrong package insert was included in the shipping materials.
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 documentation error (wrong package insert) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
CooperSurgical, Inc. D.B.A. Lone Star Medical Products is recalling 90 units of the Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer. The recall involves Lots 149460 and 149911 of product code 900-863. The reason for the recall is that the wrong package insert (Instructions for Use) was placed into the shipper.
The affected products were distributed nationwide in the United States to North Carolina, as well as internationally to Australia and Italy. The source text does not report any illnesses, injuries, or adverse health consequences associated with this recall.
Healthcare providers and consumers who have these specific lots should stop using the product and contact the recalling firm for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
- Hazard
- Affected units
- 90
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)
- Lots 149460 and 149911
Distribution
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