Ethicon Endopath ETS-FLEX Endoscopic Linear Cutter Recalled for Gear Failure Risk
Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter due to a risk of pinion gear failure under extreme use cases.
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. The hazard involves a mechanical component failure (pinion gear) in a medical device, which poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM. The recall affects specific lot codes: N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G.
The recall was initiated because there is a risk that the pinion gear in the device could fail under extreme use cases. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The affected products were distributed worldwide, with specific distribution noted in China, Japan, Singapore, and South Korea. Healthcare providers and facilities should stop using the affected devices and contact Ethicon Endo-Surgery Inc for further instructions on the recall.
The recalled product
- Product
- Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- Affected units
- 792
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 (5)
- N91U0W
- N91U0X
- N91L2P
- N91N1J
- and N91N2G
Distribution
Distribution scope not specified by the agency.
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