Ethicon Recalls Disposable Curved Circular Staplers Due to Malformed Staple Risk
Ethicon Endo-Surgery Inc is recalling specific lots of disposable curved circular staplers because they may create staples that do not meet height specifications, resulting in malformed staples.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (malformed staples in surgical anastomoses) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling specific lots of Disposable Curved Circular Staplers. The affected products are used throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. The recall involves product codes CCS25 and CCS29, with a total quantity of 148.913 units. The distribution pattern is listed as China.
The recall is being issued because there is a potential for the devices to create staples that do not meet formed staple height specifications. This defect can result in malformed staples. The U.S. Food and Drug Administration has classified this recall as Class II.
Healthcare providers and facilities that have received these specific product codes should stop using the affected devices and contact the recalling firm for instructions on return or replacement. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
- Manufacturer
- Ethicon Endo-Surgery Inc
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 (2)
- CCS25
- CCS29
Distribution
Distribution scope not specified by the agency.
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